Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2011 |
| End Date: | December 2012 |
| Contact: | Carina Gregory |
| Email: | cgregory@medinst.com |
| Phone: | 765-463-7537 |
Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
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.
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.
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