Registry Study of Transoral Incisionless Fundoplication Using the EsophyX Device for Treating Chronic Gastroesophageal Reflux Disease with 5-Year Follow-Up

What this Trial Is About

Researchers are observing patients with gastro-esophageal reflux disease GERD who undergo transoral incisionless fundoplication TIF using the EsophyX device. The study aims to record TIF procedures in patients with esophageal or extra-esophageal symptoms, monitor therapy responses including changes in proton pump inhibitor use and symptom questionnaire scores, and identify patient characteristics and factors that predict TIF success. Patients treated with TIF by the EsophyX device will be enrolled in a registry and followed clinically for five years after their procedure. The intervention creates a new valve at the gastroesophageal junction using an endoscopic technique that places multiple sutures to reduce reflux, similar to surgical fundoplication. The registry involves routine post-TIF visits and examinations to track outcomes over time. Participants will be monitored through yearly assessments of medication use and dosage, along with quality of life and reflux symptom questionnaires. Additional evaluations such as esophageal examinations, grading of the gastro-esophageal valve, esophageal manometry, pH-metry, and impedancemetry will occur at specified intervals up to two years post-procedure. The total follow-up period for each participant is five years to gather long-term data on treatment effects and patient outcomes.

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