This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Gastro Esophageal Reflux Device: Transoral incisionless fundoplication

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. High-resolution esophageal manometry findings [ Time Frame: 12 months after the date of the intervention ]
    Esophageal manometry measurements after the intervention

  8. 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

  9. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05066594


Contacts
Layout table for location 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

Locations
Layout table for location information
Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
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   
Principal Investigator: Pier Alberto Testoni, MD, Prof.         
Sub-Investigator: Sabrina Gloria Giulia Testoni, MD, PhD         
Sub-Investigator: Sandro Passaretti, MD         
Sub-Investigator: Emanuela Ribichini, MD, PhD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Layout table for investigator information
Principal Investigator: Pier Alberto Testoni, Prof. IRCCS San Raffaele
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pier Alberto Testoni, Head of Gastroenterology and Digestive Endoscopy, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT05066594    
Other Study ID Numbers: TIF REGISTRY 2021
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021

Layout table for additional information
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
Keywords provided by Pier Alberto Testoni, IRCCS San Raffaele:
Fundoplication
Endoscopy, Digestive System
Gastro Esophageal Reflux
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases