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)
Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months. Patients must have a positive pH test and a negative manometry (no treatment) procedure.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months
• Objective evidence of reflux disease (positive ambulatory pH study.)
Locations
United States
Missouri
Kansas City VA Hospital
RECRUITING
Kansas City
Contact Information
Primary
April Higbee, BSN
april.higbee@va.gov
816-861-4700
Backup
Carlissa Campbell, MS
Carlissa.Campbell@va.gov
816-861-4700
Time Frame
Start Date: 2022-02-15
Completion Date: 2025-04
Participants
Target number of participants: 36
Treatments
Active_comparator: Anti-reflux mucosal ablation (ARAT)
ablation in the gastric cardia using hybrid argon plasma coagulation
Sham_comparator: No treatment
no ablation
Related Therapeutic Areas
Sponsors
Leads: Midwest Veterans' Biomedical Research Foundation