Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation in Gastroesophageal Reflux Disease Patients: A Randomized, Sham-Controlled Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Anti-Reflux Argon Plasma Therapy (ARAT) in people with chronic gastroesophageal reflux disease (GERD) symptoms, such as heartburn or acid reflux at least twice a week for the last six months. This randomized clinical trial requires participants to have a positive pH test confirming reflux and a negative manometry test, meaning no treatment is needed for esophageal motility. The study is sponsored by the Midwest Veterans' Biomedical Research Foundation. Participants will be randomly assigned to one of two groups. The ARAT group will receive a specialized endoscopic procedure using pulsed argon plasma coagulation to ablate tissue in the gastric cardia area, involving cleaning, marking, injection, and targeted treatment of the mucosa. The control group will undergo a sham procedure involving upper endoscopy with sedation and careful examination but no ablation or injection. All participants will continue daily proton pump inhibitor (PPI) medication for four weeks after the procedure. During the study, participants will be followed for up to 12 months with assessments at 3, 6, and 12 months. Researchers will measure changes in GERD-related quality of life, reflux symptoms, PPI use, acid exposure time, incidence of esophagitis, and hiatal hernia grading. Safety will be monitored through adverse event tracking at multiple time points after randomization. The total duration of involvement allows careful evaluation of the treatment's impact on symptoms and safety over time.

Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)