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

This study has been terminated.
Information provided by (Responsible Party):
Cook Identifier:
First received: September 9, 2010
Last updated: June 17, 2015
Last verified: June 2015

September 9, 2010
June 17, 2015
June 2011
September 2012   (Final data collection date for primary outcome measure)
Reduction of reflux symptoms measured by GERD HRQL [ Time Frame: 6 months ]
HRQL = Health Related Quality of Life Questionnaire
Same as current
Complete list of historical versions of study NCT01199679 on Archive Site
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring [ Time Frame: 6 months ]
Same as current
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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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Principal Investigator: Glen A. Lehman, MD Indiana University Hospital
June 2015

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