Endoscopic anti-reflux treatment with APC for people with GERD
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)
Run by Midwest Veterans' Biomedical Research Foundation · NCT05570448 · Data updated 2026-11-12
This trial will test whether ARAT—an endoscopic anti-reflux procedure using argon plasma coagulation (APC)—can reduce chronic heartburn and acid reflux in adults who have a positive pH test and normal esophageal manometry.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Midwest Veterans' Biomedical Research Foundation Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | February 15, 2022 |
| Main results expected | February 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT05570448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 80 with chronic typical GERD symptoms at least twice weekly for six months, a positive ambulatory pH study, and normal esophageal manometry are the intended participants.
✕Probably not a fit
Patients with large hiatal hernias (>3 cm) or Hill grade IV, Barrett's esophagus, prior fundoplication/myotomy/LINX, major motility disorders, eosinophilic esophagitis, gastroparesis, cirrhosis with varices, or PPI allergy/intolerance are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, sham-controlled trial will compare ARAT (argon plasma coagulation-based endoscopic treatment) to a sham intervention in adults with chronic GERD and abnormal ambulatory pH testing. Eligible participants must have typical GERD symptoms at least twice weekly for six months and objective evidence of reflux on pH monitoring, with no major motility disorder on manometry. Participants will be randomized to receive the active endoscopic procedure or a sham procedure and followed for symptom changes and safety outcomes. Outcomes will focus on reduction in reflux symptoms and procedure-related adverse events over the follow-up period.
Why it matters
Potential benefit: If successful, ARAT could reduce dependence on daily proton-pump inhibitors and offer a less invasive alternative to surgery for some patients with chronic GERD.
How similar studies have gone: Some endoscopic anti-reflux approaches have shown symptom improvement in prior studies, but APC-based ARAT is relatively novel and not yet widely validated in randomized sham-controlled trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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.) Exclusion Criteria: * Patients unable to or unwilling to participate or consent. * Age \<18 years or \>80 years. * Allergic or intolerant to PPI medications. * Large hiatal hernia \> 3 cm and Hill grade IV. * Barrett's esophagus. * Esophageal stricture with any prior intervention. * Major motility disorder. * Eosinophilic esophagitis. * Gastroparesis documented by abnormal gastric emptying time. * Previous fundoplication, myotomy or LINX surgery. * Cirrhosis with esophageal and/or gastric varices.
Where it's running
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Kansas City VA Hospital
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Prateek Sharma, MD — Kansas City VA Hospital
- Study coordinator: April Higbee, BSN
- Email: april.higbee@va.gov
- Phone: 816-861-4700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.