Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study) (AREA21)

February 26, 2026 updated by: Midwest Veterans' Biomedical Research Foundation

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Kansas City VA Hospital
        • Principal Investigator:
          • Prateek Sharma, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Madhav Desai, MD
        • Sub-Investigator:
          • Abhilash Perisetti, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anti-reflux mucosal ablation (ARAT)
ablation in the gastric cardia using hybrid argon plasma coagulation
Procedure: ARAT
For patients randomized to ARAT intervention, the area of cardia, along greater curvature will be cleaned followed by demarcation of a 1-1.5 cm area of non-ablation zone with two vertical lines by use of Pulsed APC (30W, Effect 2) using the H-APC catheter. Next, the area of cardia, on either side will be injected in sequence using a methylene blue (0.5%) and normal saline (0.9%) using the H-APC catheter jet system (Effect 30-70). Next, the mucosa, starting below the z-line and up to 3 cm below will be treated by Pulsed APC 50W-80W till golden-brown discoloration of the ablated tissue in 270-320 degree. For patients randomized to control or sham intervention, upper endoscopy with procedural sedation was performed followed by markings of landmarks followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time. No H-APC or submucosal injection or other intervention will be performed.
Other Names:
  • Anti-reflux mucosal ablation
Sham Comparator: No treatment
no ablation
Procedure: Sham intervention (control)
Patients randomized to the control arm, will undergo a sham intervention. This will include performing upper endoscopy with procedural sedation followed by markings of landmarks as described. This will be followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time spent in retroflexion to reciprocate the H-APC intervention. No H-APC or submucosal injection or other intervention will be performed during the upper endoscopy with sham intervention. All Patients will also continue their PPI daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GERD health related quality of life (GERD-HRQL) score
Time Frame: At 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.
At 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Reflux disease questionnaire (RDQ) score
Time Frame: At 3, 6 and 12 months
RDQ scores will be assessed using a validated questionnaire scale. The total score is 40, and a higher score is associated with more severe symptoms.
At 3, 6 and 12 months
Change in Proton pump inhibitor (PPI) use
Time Frame: At 3, 6 and 12 months
Frequency of PPI medication use
At 3, 6 and 12 months
Acid exposure time (AET)
Time Frame: At 3 and 12 months
Ambulatory acid reflux testing (wireless pH monitoring system) for measurement. Acid exposure time measures amount of time spent in pH <4. A time >4% is considered positive for acid reflux.
At 3 and 12 months
Adverse events
Time Frame: Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)
Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization
Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)
Change in Hiatal hernia grading
Time Frame: At 3 and 12 months
Hill grade for hiatal hernia assessment during endoscopy. There are 4 grades: I, II, III and IV depending on the appearance of the hiatus on endoscopy.
At 3 and 12 months
Esophagitis incidence
Time Frame: At 3 and 12 months
LA grade esophagitis at the time of endoscopy
At 3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Veterans' Biomedical Research Foundation

Investigators

  • Study Director: Madhav Desai, MD, Kansas City VA Hospital
  • Principal Investigator: Prateek Sharma, MD, Kansas City VA Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0100
  • 1650419 (Other Identifier: IRBnet)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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