Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gastro Esophageal Reflux

In brief

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.

Key facts

Study ID

NCT05570448

Run by

Midwest Veterans' Biomedical Research Foundation

People needed

36

Starts

2022-02-15

Expected to finish

2027-04-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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 is running

• Kansas City VA Hospital — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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