NCT01199679

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

Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease
• Heartburn
• Regurgitation
• Dyspepsia

Interventions

Type	Name	Description
PROCEDURE	Mucosectomy	Endoscopic mucosal resection in the upper GI tract.
PROCEDURE	Rubber Band Ligation	Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-09-01
• Completion: 2013-03-01
• First posted: 2010-09-13
• Last updated: 2015-06-19

Locations

1 site across 1 country: United States