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

Gastroesophageal Reflux Disease Clinical Trial

— GERD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01199679
• Other study ID #: 08-016
• Status: Terminated
• Phase: N/A
• First received: September 9, 2010
• Last updated: June 17, 2015
• Start date: June 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn
• Regurgitation

Intervention

Procedure:
• Mucosectomy
Endoscopic mucosal resection in the upper GI tract.
• Rubber Band Ligation
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of reflux symptoms measured by GERD HRQL	HRQL = Health Related Quality of Life Questionnaire	6 months	Yes
Secondary	Reduction in total esophageal acid exposure measured by 48 hour pH monitoring		6 months	No