Minimally Invasive Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation for Chronic GERD in Adults

What this Trial Is About

Researchers are evaluating a new minimally invasive endoscopic therapy called antireflux mucosal ablation ARAT using hybrid argon plasma coagulation for adults with chronic gastroesophageal reflux disease GERD. This condition affects many adults who continue to have symptoms despite medical therapy. The study aims to compare the safety and effectiveness of ARAT to a sham procedure in patients with typical GERD symptoms at least twice a week for six months and objective evidence of reflux. Participants will be randomly assigned to receive either the ARAT intervention or a sham procedure. The ARAT treatment involves cleaning and marking the cardia area of the stomach followed by injections to raise the mucosa and targeted ablation using pulsed argon plasma coagulation. The sham group will undergo a similar endoscopic examination without ablation or injections. Patients continue their proton pump inhibitor PPI medication daily for four weeks after the procedure. Follow-up visits are scheduled at 3, 6, and 12 months to assess outcomes. During the study, participants will have upper endoscopies and ambulatory pH monitoring at 3 and 12 months, along with completing validated GERD symptom questionnaires. Phone calls for adverse event monitoring occur shortly after the procedure and at 1 month. Researchers will measure changes in GERD symptom scores, esophageal acid exposure, and PPI use over one year. Patients with any complications such as dysphagia will receive appropriate evaluation and treatment. The total study duration from randomization to completion is one year, with an overall project timeline of about 24 months including screening and data analysis.

Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)