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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Oct 2023 to Mar 2024v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06106100
Lead Sponsor Far Eastern Memorial Hospital
Conditions
(from sponsor)		 Gastroesophageal Reflux Disease
Related terms Gastroesophageal Reflux
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov