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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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05066594
Study type Observational [Patient Registry]
Source IRCCS San Raffaele
Contact Pier Alberto Testoni, MD, Prof.
Phone +39 02/26432756
Email [email protected]
Status Recruiting
Start date May 1, 2021
Completion date May 2029

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