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

Launched by FAR EASTERN MEMORIAL HOSPITAL · Oct 26, 2023

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)