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NCT05570448NARecruiting

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

Midwest Veterans' Biomedical Research Foundation

Start Date

2/15/2022

Completion Date

4/1/2027

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 Criteria

Age Range: 18 years to 80 years

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.

Interventions

PROCEDURE

ARAT

PROCEDURE

Sham intervention (control)

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Conditions

Gastro Esophageal Reflux

Locations

Kansas City VA Hospital

Kansas City, Missouri 64128

United States