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The AREA Study: ARAT for Chronic GERD

This study is looking at a procedure called ARAT (Anti-Reflux Endoscopic TX Using APC) for people with chronic GERD (Gastroesophageal Reflux Disease). GERD causes symptoms like heartburn or acid reflux at least twice a week. We want to see if ARAT is safe and effective in improving your quality of life compared to a sham (control) procedure. You might be able to join if you are between 18 and 80 years old, have had GERD symptoms for at least 6 months, and have a positive pH test showing reflux. The study plans to enroll 36 participants. We will measure changes in your GERD-related quality of life over 12 months.

Study design
This is a randomized clinical trial, meaning participants will be randomly assigned to receive either the ARAT procedure or a sham procedure. The study plans to enroll 36 participants.
What's involved
If you participate, you will undergo an upper endoscopy with sedation. Your GERD-related quality of life will be measured at 3, 6, and 12 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the procedure to assess changes in their GERD-related quality of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05570448

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

Recruiting
NAAges 18–80InterventionalTreatment
Midwest Veterans' Biomedical Research Foundation
~36 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:ARATSham intervention (control)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in GERD health related quality of life (GERD-HRQL) score
Measured over At 3, 6 and 12 months

Conditions

Gastro Esophageal Reflux

Explore related trials

Gastroesophageal Reflux Disease

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Prateek Sharma, MD · PRINCIPAL_INVESTIGATOR · Kansas City VA Hospital
  • Madhav Desai, MD · STUDY_DIRECTOR · Kansas City VA Hospital

Who to contact

April Higbee, BSN
[email protected]
816-861-4700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in GERD health related quality of life (GERD-HRQL) scoreAt 3, 6 and 12 months

    The primary outcome of quality of life will be measured using the validated GERD related quality of life questionnaire (GERD-HRQL). The total score is 50, and a higher score is associated with more severe symptoms.