Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

Not Applicable

Terminated

• Conditions: Gastroesophageal Reflux Disease; Regurgitation; Heartburn; Dyspepsia

• 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

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2011-06
• Primary Completion: 2012-09
• Study Completion: 2013-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-19

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

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