Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
Conditions
Keywords
Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
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.
Interventions
PROCEDUREMucosectomy
Endoscopic mucosal resection in the upper GI tract.
PROCEDURERubber Band Ligation
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of reflux symptoms measured by GERD HRQL | 6 months | HRQL = Health Related Quality of Life Questionnaire |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in total esophageal acid exposure measured by 48 hour pH monitoring | 6 months |
Countries
United States
Outcome results
None listed