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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Endoscopic mucosal resection in the upper GI tract.
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Indiana University Hospital
Indianapolis, Indiana, United States
Reduction of reflux symptoms measured by GERD HRQL
HRQL = Health Related Quality of Life Questionnaire
Time frame: 6 months
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring
Time frame: 6 months
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