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Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD) (TIF/2021)

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ClinicalTrials.gov Identifier: NCT05066594
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Pier Alberto Testoni, IRCCS San Raffaele

Tracking Information
First Submitted Date April 29, 2021
First Posted Date October 4, 2021
Last Update Posted Date October 4, 2021
Actual Study Start Date May 1, 2021
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2021)		 Medical use and dosage [ Time Frame: Yearly, up to 5 years from the date of the intervention ]
Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 24, 2021)
  • Health Related Quality of Life questionnaire score [ Time Frame: Yearly, up to 5 years from the date of the intervention ]
    Modification of the scores from the gastro-esophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (absence of symptoms) to 5 (symptoms do not allow for normal daily activity), after intervention compared with baseline
  • Reflux Symptom Index questionnaire score [ Time Frame: Yearly, up to 5 years from the date of the intervention ]
    Modification of the scores from the reflux symptom index (GERD-RSI) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (no problem) to 5 (severe problem) after the intervention compared with baseline
  • Esophagitis [ Time Frame: 6 months and 12 months after the date of the intervention ]
    Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention
  • Hill's grade of the gastro-esophageal flap valve [ Time Frame: 6 months and 12 months after the date of the intervention ]
    Degree of continence of the neo gastro-esophageal flap valve according to the Hill classification (grade I, grade II, grade III, grade IV) after the intervention
  • Jobe's length of the gastro-esophageal valve [ Time Frame: 6 months and 12 months after the date of the intervention ]
    Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention
  • Barrett's esophagus [ Time Frame: 6 months and 12 months after the date of the intervention ]
    Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention
  • High-resolution esophageal manometry findings [ Time Frame: 12 months after the date of the intervention ]
    Esophageal manometry measurements after the intervention
  • 24-hour esophageal pH-metry findings [ Time Frame: 12 months and 24 months after the date of the intervention ]
    24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention
  • 24-hour esophageal impedancemetry findings [ Time Frame: 12 months and 24 months after the date of the intervention ]
    24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Official Title Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
Brief Summary This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
Detailed Description After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Inclusion criteria for TIF: >12 months esophageal or extraesophageal symptoms from gastroesophageal reflux, despite >6 months therapy with PPI; cardial valve Hill's degree >III; pathological gastroesophageal reflux; hiatal hernia ≤2 cm.

Exclusion criteria for TIF: hiatal hernia >2 cm; paraesophageal hernia; severe esophageal motility disorder or Los Angeles grade C and D esophagitis; esophageal stenosis, diverticula, infections; pregnancy, breastfeeding; bleeding disorders; malignant neoplasm; immunosuppressant therapy; portal hypertension; esophageal varices; eosinophilic esophagitis; autoimmune esophagitis; BMI ≥35; limited mobility of the neck; patients for whom the use of the EsophyX device is contraindicated.
Condition Gastro Esophageal Reflux
Intervention Device: Transoral incisionless fundoplication
The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.
Study Groups/Cohorts Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)
Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.
Intervention: Device: Transoral incisionless fundoplication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 24, 2021)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2029
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for enrollment:

  • Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
  • Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
  • Signed informed consent for participation in the observational registry.

Exclusion Criteria for enrollment:

  • Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
  • Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
  • No signed informed consent for participation in the observational registry.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pier Alberto Testoni, MD, Prof. +39 02/26432756 testoni.pieralberto@hsr.it
Contact: Sabrina Gloria Giulia Testoni, MD, PhD +39 02/26436303 testoni.sabrinagloriagiulia@hsr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05066594
Other Study ID Numbers TIF REGISTRY 2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement Not Provided
Current Responsible Party Pier Alberto Testoni, IRCCS San Raffaele
Original Responsible Party Same as current
Current Study Sponsor IRCCS San Raffaele
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Pier Alberto Testoni, Prof. IRCCS San Raffaele
PRS Account IRCCS San Raffaele
Verification Date September 2021