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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066594
Other study ID # TIF REGISTRY 2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date May 2029

Study information

Verified date September 2021
Source IRCCS San Raffaele
Contact Pier Alberto Testoni, MD, Prof.
Phone +39 02/26432756
Email testoni.pieralberto@hsr.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2029
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Italy IRCCS San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medical use and dosage Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention Yearly, up to 5 years from the date of the intervention
Secondary Health Related Quality of Life questionnaire score 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 Yearly, up to 5 years from the date of the intervention
Secondary Reflux Symptom Index questionnaire score 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 Yearly, up to 5 years from the date of the intervention
Secondary Esophagitis Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention 6 months and 12 months after the date of the intervention
Secondary Hill's grade of the gastro-esophageal flap valve 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 6 months and 12 months after the date of the intervention
Secondary Jobe's length of the gastro-esophageal valve Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention 6 months and 12 months after the date of the intervention
Secondary Barrett's esophagus Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention 6 months and 12 months after the date of the intervention
Secondary High-resolution esophageal manometry findings Esophageal manometry measurements after the intervention 12 months after the date of the intervention
Secondary 24-hour esophageal pH-metry findings 24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention 12 months and 24 months after the date of the intervention
Secondary 24-hour esophageal impedancemetry findings 24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention 12 months and 24 months after the date of the intervention
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