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

RecruitingNAAges 18 Years - 80 YearsAllMidwest Veterans' Biomedical Research Foundation
NCT05570448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • ARAT
  • Sham intervention (control)
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Where

1 site
Kansas City VA Hospital
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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