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

NCT05570448 | Recruiting

• 2 other identifiers: PS01001650419
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Change in GERD health related quality of life (GERD-HRQL) score

  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 Outcomes (6)

• Change in Reflux disease questionnaire (RDQ) score

  At 3, 6 and 12 months

• Change in Proton pump inhibitor (PPI) use

  At 3, 6 and 12 months

• Acid exposure time (AET)

  At 3 and 12 months

• Adverse events

  Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)

• Change in Hiatal hernia grading

  At 3 and 12 months

Study Arms (2)

Anti-reflux mucosal ablation (ARAT)

ACTIVE COMPARATOR

ablation in the gastric cardia using hybrid argon plasma coagulation

Procedure: ARAT

No treatment

SHAM COMPARATOR

no ablation

Procedure: Sham intervention (control)

Interventions

ARAT PROCEDURE

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.

Also known as: Anti-reflux mucosal ablation

Anti-reflux mucosal ablation (ARAT)

Sham intervention (control) PROCEDURE

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.

No treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Veterans' Biomedical Research Foundation: lead

Study Sites (1)

Kansas City VA Hospital

Kansas City, Missouri, 64128, United States

RECRUITING

Related Publications (19)

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  PMID: 16928254 RESULT

Related Links

• , Kalapala R, Nabi Z, et al. Anti-Reflux Mucosal Ablation (ARMA) For Refractory Gastroesophageal Reflux Disease - An Interim Analysis, 2021.

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prateek Sharma, MD

  Kansas City VA Hospital

  PRINCIPAL INVESTIGATOR

• Madhav Desai, MD

  Kansas City VA Hospital

  STUDY DIRECTOR

Central Study Contacts

April Higbee, BSN

CONTACT

816-861-4700; april.higbee@va.gov

Carlissa Campbell, MS

CONTACT

816-861-4700; Carlissa.Campbell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 6, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)