Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01199679
First received: September 9, 2010
Last updated: April 30, 2014
Last verified: April 2014

September 9, 2010
April 30, 2014
June 2011
September 2012   (final data collection date for primary outcome measure)
Reduction of reflux symptoms measured by GERD HRQL [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
HRQL = Health Related Quality of Life Questionnaire
Same as current
Complete list of historical versions of study NCT01199679 on ClinicalTrials.gov Archive Site
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Heartburn
  • Regurgitation
  • Dyspepsia
  • 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.
  • Experimental: Endoscopic Mucosal Resection (EMR) Group
    Intervention: Procedure: Mucosectomy
  • Experimental: Banding Group
    Intervention: Procedure: Rubber Band Ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
March 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199679
08-016
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Glen A. Lehman, MD Indiana University Hospital
Cook
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP