Actively Recruiting
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation in Gastroesophageal Reflux Disease Patients A Single Center, Randomized, Sham-Controlled Trial
Led by Asian Institute of Gastroenterology, India · Updated on 2025-02-12
18
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new minimally invasive endoscopic therapy called antireflux mucosal ablation (ARAT) using hybrid argon plasma coagulation for adults with chronic gastroesophageal reflux disease (GERD). This condition affects many adults who continue to have symptoms despite medical therapy. The study aims to compare the safety and effectiveness of ARAT to a sham procedure in patients with typical GERD symptoms at least twice a week for six months and objective evidence of reflux. Participants will be randomly assigned to receive either the ARAT intervention or a sham procedure. The ARAT treatment involves cleaning and marking the cardia area of the stomach followed by injections to raise the mucosa and targeted ablation using pulsed argon plasma coagulation. The sham group will undergo a similar endoscopic examination without ablation or injections. Patients continue their proton pump inhibitor (PPI) medication daily for four weeks after the procedure. Follow-up visits are scheduled at 3, 6, and 12 months to assess outcomes. During the study, participants will have upper endoscopies and ambulatory pH monitoring at 3 and 12 months, along with completing validated GERD symptom questionnaires. Phone calls for adverse event monitoring occur shortly after the procedure and at 1 month. Researchers will measure changes in GERD symptom scores, esophageal acid exposure, and PPI use over one year. Patients with any complications such as dysphagia will receive appropriate evaluation and treatment. The total study duration from randomization to completion is one year, with an overall project timeline of about 24 months including screening and data analysis.
CONDITIONS
Brief 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...
- Patients with chronic GERD symptoms (heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months
- Objective evidence of reflux disease with positive ambulatory pH study
- Patients prescribed standard dose of proton pump inhibitors for GERD symptoms
- Able to undergo upper endoscopy as confirmed by pre-endoscopy standard care
You will not qualify if you...
- Unable or unwilling to participate or give consent
- Age under 18 years or over 80 years
- Allergic or intolerant to proton pump inhibitor medications
- Large hiatal hernia greater than 3 cm and Hill grade IV
- Barrett's esophagus
- Esophageal stricture with any prior intervention
- Major esophageal motility disorder on high-resolution manometry
- Eosinophilic esophagitis
- Gastroparesis documented by abnormal gastric emptying
- Previous fundoplication, myotomy, or LINX surgery
- Cirrhosis with esophageal or gastric varices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with follow-up calls in the first month
Participants return to the clinic to undergo either the anti-reflux endoscopic therapy using Argon plasma coagulation or a sham endoscopy procedure.
1 intervention visit (in-person); phone calls at 24-48 hours, 7-10 days, and 25-30 days post procedure
Duration - Up to 12 months post intervention
Participants complete questionnaires and undergo assessments including upper endoscopy and ambulatory pH monitoring to evaluate treatment effects and safety over one year.
Visits at 3-4 months and 11-12 months (in-person), phone call at 6-7 months
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
R
Rajesh Goud Dr Maragoni, Bpharm, Mpharm, MBA, PGDM
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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