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) (AREA21)

  • STATUS
    Recruiting
  • End date
    Apr 22, 2025
  • participants needed
    36
  • sponsor
    Midwest Veterans' Biomedical Research Foundation
Updated on 22 October 2022

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.

Details
Condition Gastro Esophageal Reflux
Treatment ARAT, Sham intervention (control)
Clinical Study IdentifierNCT05570448
SponsorMidwest Veterans' Biomedical Research Foundation
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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