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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 and 12 months

Awards & highlights

AREA21 Trial 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.Check my eligibility

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.See study design

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.

AREA21 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in GERD health related quality of life (GERD-HRQL) score

Secondary outcome measures

Beta-Aminoethylisothiuronium Dihydrobromide

Adverse events

Change in Hiatal hernia grading

+3 more

AREA21 Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Midwest Veterans' Biomedical Research FoundationLead Sponsor

Madhav Desai, MDStudy DirectorKansas City VA Hospital

Prateek Sharma, MDPrincipal InvestigatorKansas City VA Hospital

18 Previous Clinical Trials

8,765 Total Patients Enrolled

Media Library

ARAT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05570448 — N/A

Acid Reflux Research Study Groups: Anti-reflux mucosal ablation (ARAT), No treatment

Acid Reflux Clinical Trial 2023: ARAT Highlights & Side Effects. Trial Name: NCT05570448 — N/A

ARAT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570448 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for this examination restricted to individuals of a certain age?

"This medical study is currently welcoming participants aged 18 to 80."

Answered by AI

Who qualifies to participate in this research?

"To be eligible for entry, potential participants must have gastroesophageal reflux and fit within the 18 to 80 age range. As of now, 36 patients are needed for this clinical trial."

Answered by AI

Are participants still being recruited for this research endeavor?

"The information available on clinicaltrials.gov verifies that recruitment events are taking place for this study. It was initially posted in mid-February and edited most recently during early October of 2022."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is currently seeking volunteers for participation; it was initially posted on February 15th 2022 and the most recent update occurred October 5th of the same year. The study intends to enroll 36 patients from a single medical centre."

Answered by AI