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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIRCCS San Raffaele

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transoral incisionless fundoplication

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators