TerminatedNot Applicable

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

United States10 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Reduction of reflux symptoms measured by GERD HRQL

Timeframe: 6 months

Trial details

NCT IDNCT01199679

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials