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Recruiting NCT05066594

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

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Trial Parameters

Condition Gastro Esophageal Reflux
Sponsor IRCCS San Raffaele
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-05-01
Completion 2026-05
Interventions
Transoral incisionless fundoplication

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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.

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.

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