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

M

Midwest Veterans' Biomedical Research Foundation

Status

Enrolling

Conditions

Gastro Esophageal Reflux

Treatments

Procedure: Sham intervention (control)
Procedure: ARAT

Study type

Interventional

Funder types

Other

Identifiers

NCT05570448
PS0100
1650419 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Anti-reflux mucosal ablation (ARAT)
Active Comparator group
Description:
ablation in the gastric cardia using hybrid argon plasma coagulation
Treatment:
Procedure: ARAT
No treatment
Sham Comparator group
Description:
no ablation
Treatment:
Procedure: Sham intervention (control)

Trial contacts and locations

1

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Central trial contact

April Higbee, BSN; Carlissa Campbell, MS

Data sourced from clinicaltrials.gov

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