Endoscopic Fundoplication With MUSE System

• ClinicalTrials.gov Identifier: NCT03669874
• Recruitment Status: Recruiting
• First Posted: September 13, 2018
• Last Update Posted: December 11, 2020
• Sponsor: IRCCS San Raffaele
• Information provided by (Responsible Party): Pier Alberto Testoni, IRCCS San Raffaele

Study Description

Brief Summary:

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:

• Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:

  • effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
  • effect on the use and dosage of proton pump inhibitors (PPI)
  • feasibility and safety of the endoluminal fundoplication procedure
• Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

• 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
• 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
• Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Condition or disease	Intervention/treatment
Gastro-esophageal Reflux; Endoscopic Fundoplication	Device: Endoscopic fundoplication

Study Design

• Study Type: Observational
• Estimated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
• Actual Study Start Date: September 16, 2015
• Estimated Primary Completion Date: September 16, 2021
• Estimated Study Completion Date: September 2026

Groups and Cohorts

Intervention Details:

• Device: Endoscopic fundoplication

  Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.

  The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.

Outcome Measures

Primary Outcome Measures :

1. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 6 months ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
2. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 12 months ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
3. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 24 months ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
4. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 3 years ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
5. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 4 years ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
6. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 5 years ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
7. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 6 years ]
   GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
8. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 6 months ]
   RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
9. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 12 months ]
   RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
10. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 24 months ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
11. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 3 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
12. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 4 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
13. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 5 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
14. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 6 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
15. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 6 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
16. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 12 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
17. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 24 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
18. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 3 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
19. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 4 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
20. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 5 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
21. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 6 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

Secondary Outcome Measures :

1. To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 6 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
2. To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 12 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
3. To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 6 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
4. To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 12 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
5. To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 6 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
6. To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 12 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
7. To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 6 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
8. To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 12 months ]
   Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
9. To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 6 months ]
   parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
10. To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
11. To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
12. To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
13. To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
14. To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
15. To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
16. To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
17. To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
18. To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
19. To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
20. To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
21. To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
22. To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
23. To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
24. To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
25. To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
26. To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
27. To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
28. To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
29. To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
30. To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
31. To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
32. To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
33. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
34. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
35. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
36. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
37. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
38. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
39. To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
40. To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
41. To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
42. To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
43. To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
44. To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
45. To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
46. To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
47. To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
48. To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Probability Sample

Study Population

Patients are selected from tertiary care center

Criteria

Inclusion Criteria:

• Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
• Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
• Indication to surgical fundoplication
• Patients available for a long-term follow-up

Exclusion Criteria:

• Hiatal hernia ≥ 3 cm
• Major esophageal motility disorder
• Esophageal stenosis
• Malignant neoplasia (except minor superficial skin neoplasm)
• Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
• Previous cardiac, thoracic or upper GI surgery
• BMI >40
• Pregnancy or breast feeding

Contacts and Locations

Contacts

Contact: Pier Alberto Testoni, Professor; +390226432756; testoni.pieralberto@hsr.it

Locations

Italy

Pier Alberto Testoni; Recruiting

Milan, Italy, 20132

Contact: Pier Alberto Testoni, MD 00390226432756

Sponsors and Collaborators

IRCCS San Raffaele

Investigators

• Principal Investigator: Pier Alberto Testoni, Professor; San Raffaele Scientific Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.

Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.

• Responsible Party: Pier Alberto Testoni, Professor, IRCCS San Raffaele
• ClinicalTrials.gov Identifier: NCT03669874
• Other Study ID Numbers: MUSE/2015
• First Posted: September 13, 2018
• Last Update Posted: December 11, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophagitis, Peptic; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases