Actively Recruiting
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)
Led by Asian Institute of Gastroenterology, India · Updated on 2025-02-12
18
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background and Rationale: Gastroesophageal reflux disease is affecting 1 in 3 US adults with half experiencing daily symptoms. Per recent data, more than 50% continue to experience daily symptoms despite taking medical therapy and not eligible for surgery. In that small fraction of patients who are eligible for surgery, more than 70% resume taking a medicine for their reflux disease. GERD is common among the US veterans and currently there is a lack of minimally invasive endoscopic therapies for management of GERD. This study will investigate performance of minimally invasive, endoscopic therapy using antireflux mucosal ablation (hybrid argon plasma coagulation) that has been used in other areas of GI tract with efficacy and safety for management of chronic GERD among the US veterans. Objective: The aim of this study is to assess the safety and effectiveness of antireflux mucosal ablation or ARAT (intervention group) in patients with chronic gastroesophageal reflux disease (GERD) symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months and objective evidence of reflux disease (positive ambulatory pH study off PPI for 5-7 days) compared to sham procedure (control group).
CONDITIONS
Official Title
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic GERD symptoms with at least one typical symptom (heartburn or acid reflux/regurgitation) at least twice a week for the last 6 months
- Objective evidence of reflux disease confirmed by positive ambulatory pH study
- Prescribed standard dose of proton pump inhibitors (PPI) for GERD symptoms
- Able to undergo upper endoscopy as confirmed by pre-endoscopy standard of care checklist
You will not qualify if you...
- Unable or unwilling to participate or provide consent
- Age below 18 years or above 80 years
- Allergy or intolerance to PPI medications
- Large hiatal hernia greater than 3 cm and Hill grade IV
- Barrett's esophagus
- Esophageal stricture with prior intervention
- Major motility disorder on high-resolution manometry
- Eosinophilic esophagitis
- Gastroparesis with abnormal gastric emptying time
- Prior fundoplication, myotomy, or LINX surgery
- Cirrhosis with esophageal and/or gastric varices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
R
Rakesh Dr Kalapala, MBBS MD DNB
CONTACT
R
Rajesh Goud Dr Maragoni, Bpharm, Mpharm, MBA, PGDM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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