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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMidwest Veterans' Biomedical Research Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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.)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ARAT
  • Sham intervention (control)

Treatment groups

36 Participants
are divided into 2 treatment groups