Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)

Launched by ASIAN INSTITUTE OF GASTROENTEROLOGY, INDIA · Oct 12, 2024

Keywords

ClinConnect Summary

The AREA Study is researching a new treatment for gastroesophageal reflux disease (GERD), a common condition that affects many adults in the U.S., causing symptoms like heartburn and acid reflux. This trial is looking at a minimally invasive procedure called antireflux mucosal ablation, which uses a special technology (argon plasma coagulation) to help manage GERD symptoms. The goal is to see if this treatment is safe and effective for patients who have chronic GERD symptoms and have not found relief with standard medications.

To be eligible for the study, participants should be between 18 and 80 years old, have experienced GERD symptoms at least twice a week for the last six months, and have had testing that shows evidence of reflux disease. Participants will be randomly assigned to either receive the new treatment or a sham (placebo) procedure, meaning they won't know which one they are getting. The study is currently recruiting participants, and it is important for anyone interested to discuss with their doctor to see if they qualify and to learn more about what participation involves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with 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 and
• • Objective evidence of reflux disease (positive ambulatory pH study)
• • Patients prescribed standard dose of PPI for symptoms of GERD
• • Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist.
• Exclusion Criteria:
• • 1. Patients unable to or unwilling to participate or consent
• • 2. Age \<18 years or \>80 years
• • 3. Allergic or intolerant to PPI medications
• • 4. Large hiatal hernia \> 3 cm and Hill grade IV
• • 5. Barrett's esophagus
• • 6. Esophageal stricture with any prior intervention
• • 7. Major motility disorder on HRM
• • 7. Eosinophilic esophagitis 8. Gastroparesis documented by abnormal gastric emptying time 9. Previous fundoplication, myotomy or LINX surgery 10. Cirrhosis with esophageal and/or gastric varices