Status:
NOT_YET_RECRUITING
Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease
Lead Sponsor:
Far Eastern Memorial Hospital
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 tria...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06106100
Start Date
March 1 2024
End Date
October 1 2027
Last Update
February 23 2024
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