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)
Conditions
Gastro Esophageal Reflux
Locations
Kansas City VA Hospital
Kansas City, Missouri 64128
United States