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ARAT for Acid Reflux (AREA21 Trial)
N/A
Recruiting
Led By Prateek Sharma, MD
Research Sponsored by Midwest Veterans' Biomedical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6 and 12 months
Summary
This trial will examine if the ARAT is an effective and safe treatment for patients with chronic GERD symptoms.
Who is the study for?
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.
What is being tested?
The AREA Study is testing ARAT's effectiveness in treating chronic GERD symptoms against a sham (fake) procedure as control. Participants will be randomly assigned to either receive ARAT or the sham intervention to compare outcomes.
What are the potential side effects?
While specific side effects of ARAT aren't listed here, endoscopic treatments can generally cause sore throat, abdominal pain, nausea, potential bleeding or infection at the treatment site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in GERD health related quality of life (GERD-HRQL) score
Secondary study objectives
Beta-Aminoethylisothiuronium Dihydrobromide
Adverse events
Change in Hiatal hernia grading
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Anti-reflux mucosal ablation (ARAT)Active Control1 Intervention
ablation in the gastric cardia using hybrid argon plasma coagulation
Group II: No treatmentPlacebo Group1 Intervention
no ablation
Find a Location
Who is running the clinical trial?
Midwest Veterans' Biomedical Research FoundationLead Sponsor
Prateek Sharma, MDPrincipal InvestigatorKansas City VA Hospital
18 Previous Clinical Trials
8,765 Total Patients Enrolled
Madhav Desai, MDStudy DirectorKansas City VA Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a large hiatal hernia over 3 cm and it's very severe.I am younger than 18 or older than 80.I have Barrett's esophagus.I am willing and able to participate in this study.I have been diagnosed with eosinophilic esophagitis.I have had treatment for a narrowed esophagus.I have had surgery for acid reflux or esophagus issues.I have had heartburn or acid reflux at least twice a week for the last 6 months.I have cirrhosis with varices in my esophagus or stomach.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-reflux mucosal ablation (ARAT)
- Group 2: No treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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