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

Description

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.

Conditions

Gastro Esophageal Reflux

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Gastro Esophageal Reflux
Intervention / Treatment

-

Contacts and Locations

Kansas City

Kansas City VA Hospital, Kansas City, Missouri, United States, 64128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.)
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Midwest Veterans' Biomedical Research Foundation,

Prateek Sharma, MD, PRINCIPAL_INVESTIGATOR, Kansas City VA Hospital

Madhav Desai, MD, STUDY_DIRECTOR, Kansas City VA Hospital

Study Record Dates

2025-04