NCT05066594

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

Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2026-05-01
• Completion: 2029-05-01
• First posted: 2021-10-04
• Last updated: 2021-10-04

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study