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

Recruitingn/aAges 18 Years - 80 YearsAllIRCCS San Raffaele
NCT05066594 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Transoral incisionless fundoplication
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Where

1 site
IRCCS San Raffaele
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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