Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
Not Applicable
Terminated
- Conditions
- Gastroesophageal Reflux DiseaseRegurgitationHeartburnDyspepsia
- Interventions
- Procedure: MucosectomyProcedure: Rubber Band Ligation
- Registration Number
- NCT01199679
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Subject is 18 years of age or older.
- Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy.
- Subject agrees to participate and signs consent form.
Exclusion Criteria
- Patient is pregnant.
- Patient has a hiatal hernia greater than 2cm.
- Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week).
- Active medical condition that would preclude the subject from finishing this study.
- BMI > 39.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopic Mucosal Resection (EMR) Group Mucosectomy - Banding Group Rubber Band Ligation -
- Primary Outcome Measures
Name Time Method Reduction of reflux symptoms measured by GERD HRQL 6 months HRQL = Health Related Quality of Life Questionnaire
- Secondary Outcome Measures
Name Time Method Reduction in total esophageal acid exposure measured by 48 hour pH monitoring 6 months
Trial Locations
- Locations (1)
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States