Status:
TERMINATED
Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Cook Group Incorporated
Conditions:
Gastroesophageal Reflux Disease
Heartburn
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01199679
Start Date
June 1 2011
End Date
March 1 2013
Last Update
June 19 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202