Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease

The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate : * Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score * Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment. The primary endpoint will be symptoms relief (GERD-HRQL decreases \> 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.

NCT Number	NCT06106100
Lead Sponsor	Far Eastern Memorial Hospital
Conditions	Gastroesophageal Reflux Disease
Enrollment	68 participants
Start Date	2024-03
Primary Completion	2026-10 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2024-02-23