Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
GERD
Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 19, 2015
June 1, 2015
1.3 years
September 9, 2010
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of reflux symptoms measured by GERD HRQL
HRQL = Health Related Quality of Life Questionnaire
6 months
Secondary Outcomes (1)
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring
6 months
Study Arms (2)
Endoscopic Mucosal Resection (EMR) Group
EXPERIMENTALBanding Group
EXPERIMENTALInterventions
Endoscopic mucosal resection in the upper GI tract.
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glen A. Lehman, MD
Indiana University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 13, 2010
Study Start
June 1, 2011
Primary Completion
September 1, 2012
Study Completion
March 1, 2013
Last Updated
June 19, 2015
Record last verified: 2015-06