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

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ClinicalTrials.gov Identifier: NCT01199679
Recruitment Status : Terminated
First Posted : September 13, 2010
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Heartburn Regurgitation Dyspepsia Procedure: Mucosectomy Procedure: Rubber Band Ligation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Endoscopic Mucosal Resection (EMR) Group Procedure: Mucosectomy
Endoscopic mucosal resection in the upper GI tract.
Experimental: Banding Group Procedure: Rubber Band Ligation
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.



Primary Outcome Measures :
  1. Reduction of reflux symptoms measured by GERD HRQL [ Time Frame: 6 months ]
    HRQL = Health Related Quality of Life Questionnaire


Secondary Outcome Measures :
  1. Reduction in total esophageal acid exposure measured by 48 hour pH monitoring [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199679


Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Glen A. Lehman, MD Indiana University Hospital

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01199679     History of Changes
Other Study ID Numbers: 08-016
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Cook Group Incorporated:
Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyspepsia
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms