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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Midwest Veterans' Biomedical Research Foundation
Study ID
NCT05570448
Status
Recruiting
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Conditions

  • Gastro Esophageal Reflux

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2022
Status verified
Feb 2026
Primary completion
Feb 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Anti-reflux mucosal ablation (ARAT)
    ablation in the gastric cardia using hybrid argon plasma coagulation
  • Sham Comparator: No treatment
    no ablation

Primary Outcome Measure

Change in GERD health related quality of life (GERD-HRQL) score [ Time Frame: At 3, 6 and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kansas City VA HospitalKansas CityMissouri64128
April Higbee, BSN
[email protected]
816-861-4700
Carlissa Campbell, MA
[email protected]
816-861-4700
Prateek Sharma, MD (PRINCIPAL_INVESTIGATOR)
Madhav Desai, MD (SUB_INVESTIGATOR)
Abhilash Perisetti, MD (SUB_INVESTIGATOR)

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By research site
Kansas City VA Hospital· Kansas City, MO

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