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Search / Trial NCT06106100

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

Launched by FAR EASTERN MEMORIAL HOSPITAL · Oct 26, 2023

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called anti-reflux mucosal ablation (ARMA) for people suffering from gastroesophageal reflux disease (GERD) who haven’t found relief with standard medication, specifically proton pump inhibitors (PPIs). The aim is to see if ARMA can help reduce symptoms better than just taking medication alone. Participants will be randomly placed into two groups: one group will receive the ARMA treatment, while the other will undergo a sham (fake) procedure, meaning they won’t actually receive the treatment but will go through a similar process. The researchers will measure how well the treatment works by looking at symptom relief and other health indicators.

To be eligible for this trial, participants must be adults over 18 years old who have been experiencing GERD symptoms for more than six months and have been using PPIs without sufficient relief. They should also have a specific level of acid exposure in the esophagus. However, certain conditions like pregnancy, obesity, or previous surgeries related to the stomach and esophagus may exclude someone from participating. The trial is not yet recruiting, but once it starts, participants can expect to be monitored closely for both the effectiveness of the treatment and any potential side effects. This study aims to provide valuable information that could improve treatment options for people with persistent GERD symptoms.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults aged over 18 years old
  • History of GERD for over 6 months, who had received PPIs for over 6 months but still had symptoms of typical GERD symptoms (GERD-HRQL score of \>8, acid reflux sensation or heartburn), and/or other symptoms as lump throat, night cough, acid related chest tightness (without other possible explanation of these symptoms)
  • Acid exposure time \> 6%
  • DeMeester score ≥ 14.72
  • Exclusion Criteria:
  • Pregnancy
  • BMI\>=35
  • Hiatal hernia \> 2cm or Flap Valve Hill grade III/IV
  • GERD LA grade C/D or esophageal ulcer
  • Abnormal anatomy of esophagus (esophagectomy, stricture, diverticulum)
  • Barrett's esophagus with dysplasia
  • Esophageal motility disorders
  • History of gastroparesis
  • Cirrhosis
  • Esophageal and gastric varices
  • Previous gastric surgery and anti-reflux procedures
  • History of scleroderma or dermatomyositis
  • Coagulation disorders (Bleeding tendency and coagulopathy)
  • History of oncological disease (not active within 2 years)

About Far Eastern Memorial Hospital

Far Eastern Memorial Hospital is a leading healthcare institution in Taiwan, renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a focus on multidisciplinary collaboration, the hospital integrates cutting-edge technology and evidence-based practices to conduct rigorous clinical studies across various therapeutic areas. Far Eastern Memorial Hospital prioritizes patient safety and ethical standards, ensuring that all trials are designed to enhance medical knowledge and contribute to the development of new treatments. Its experienced team of researchers and healthcare professionals is dedicated to fostering a research environment that supports scientific discovery and enhances health outcomes for diverse patient populations.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported