Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01199679
First received: September 9, 2010
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia
 Procedure: Mucosectomy
Procedure: Rubber Band Ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Reduction of reflux symptoms measured by GERD HRQL [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    HRQL = Health Related Quality of Life Questionnaire


Secondary Outcome Measures:
  • Reduction in total esophageal acid exposure measured by 48 hour pH monitoring [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199679

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01199679     History of Changes
Other Study ID Numbers: 08-016
Study First Received: September 9, 2010
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia

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

ClinicalTrials.gov processed this record on May 23, 2013