ARAT for Acid Reflux
(AREA21 Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is ARAT treatment generally safe for humans?
ARAT treatments like abiraterone, enzalutamide, apalutamide, and darolutamide have been used for prostate cancer and can cause side effects like changes in hormone levels, muscle loss, and effects on the brain. However, these treatments are generally considered safe for use in humans, with side effects being monitored and managed by healthcare providers.12345
Who Is on the Research Team?
Prateek Sharma, MD
Principal Investigator
Kansas City VA Hospital
Madhav Desai, MD
Principal Investigator
Kansas City VA Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with chronic GERD, experiencing heartburn or acid reflux at least twice a week for the past 6 months. They must have confirmed acid reflux via a pH test but no major esophagus movement issues. Excluded are those with certain esophageal conditions, previous surgeries, severe liver disease, allergies to PPIs, and very large hiatal hernias.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anti-reflux mucosal ablation using hybrid argon plasma coagulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARAT
- Sham intervention (control)
ARAT is already approved in United States, European Union, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Midwest Veterans' Biomedical Research Foundation
Lead Sponsor