Minimally invasive endoscopic therapy for chronic GERD
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients
This study is testing a new, less invasive treatment for chronic GERD to see if it can help patients who haven't found relief from other treatments and aren't able to have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06641375 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of a minimally invasive endoscopic therapy called antireflux mucosal ablation (ARAT) for patients suffering from chronic gastroesophageal reflux disease (GERD). Participants will be randomized to receive either the ARAT intervention or a sham procedure. The study aims to provide a new treatment option for patients who have not found relief from standard medical therapies and are not candidates for surgery. The trial will include patients with documented GERD symptoms and will assess outcomes through follow-up visits after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic GERD symptoms and objective evidence of reflux disease.
Not a fit: Patients with severe esophageal conditions, previous surgeries for reflux, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new, effective treatment option for patients with chronic GERD who do not respond to conventional medications.
How similar studies have performed: While there is limited data on this specific approach, similar endoscopic therapies have shown promise in managing GERD in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hyderabad, Telangana
- Asian Institute of Gastroenterology Hospital — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Principal investigator: Mohan Dr Ramchandani, MBBS MD — Asian institute of Gastroenterology/AIG Hospitals
- Study coordinator: Rakesh Dr Kalapala, MBBS MD DNB
- Email: drrakesh.kalapala@aighospitals.com
- Phone: 04023378888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.