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

Stopped early · Not applicable

Conditions studied: Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

In brief

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.

Key facts

Study ID

NCT01199679

Run by

Cook Group Incorporated

People needed

10

Starts

2011-06-01

Expected to finish

2013-03-01

Last updated by the study team

2015-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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