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

Cook Group

Status

Terminated

Conditions

Heartburn

Dyspepsia

Gastroesophageal Reflux Disease

Regurgitation

Treatments

Procedure: Rubber Band Ligation

Procedure: Mucosectomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01199679

08-016

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.