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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Medical use and dosage — Yearly, up to 5 years from the date of the intervention
  Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention

Trial sites (1)

More IRCCS San Raffaele trials in Italy