NCT05570448 Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)
| NCT ID | NCT05570448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Midwest Veterans' Biomedical Research Foundation |
| Condition | Gastro Esophageal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2022-02-15 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Prateek Sharma, MD
PRINCIPAL INVESTIGATOR
Kansas City VA Hospital
Frequently Asked Questions
Who can join the NCT05570448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gastro Esophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05570448 currently recruiting?
Yes, NCT05570448 is actively recruiting participants. Contact the research team at april.higbee@va.gov for enrollment information.
Where is the NCT05570448 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT05570448 clinical trial?
NCT05570448 is sponsored by Midwest Veterans' Biomedical Research Foundation. The principal investigator is Prateek Sharma, MD at Kansas City VA Hospital. The trial plans to enroll 36 participants.