Endoscopic procedure to treat gastroesophageal reflux
Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
This study tests a new endoscopic procedure to see if it can help people with gastroesophageal reflux disease (GERD) feel better and improve their esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04194723 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of an endoscopic procedure called antireflux mucosectomy (ARMS) for patients suffering from gastroesophageal reflux disease (GERD). The study aims to establish how well this intervention works in alleviating symptoms and improving the condition of the esophagus. Participants will undergo assessments to determine their eligibility based on specific criteria related to their GERD symptoms and esophageal function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with GERD symptoms that respond to proton pump inhibitors and specific esophageal abnormalities.
Not a fit: Patients over 70 years old, pregnant individuals, or those with certain esophageal conditions like hiatus hernia may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a new treatment option for patients with GERD, potentially reducing their reliance on medication.
How similar studies have performed: Other studies have explored endoscopic treatments for GERD, showing promising results, but this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months 2. Hill's grade II and III of the gastroesophageal junction 3. One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH \< 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of \< 6mmHg or total length of less than 4cm or abdominal length of less than 2cm Exclusion Criteria: 1. Age \> 70 yrs of \< 18 yrs 2. Pregnancy 3. Any type of Hiatus hernia 4. Patients with underlying malignancy 5. ASA above grade III
Where this trial is running
Hong Kong
- Combined Endoscopy Center, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Philip Wai Yan Chiu, MD, FRCSEd
- Email: philipchiu@surgery.cuhk.edu.hk
- Phone: +85235053952
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.