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

NCT01199679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-06-19

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease
  • Heartburn
  • Regurgitation
  • Dyspepsia

Interventions

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.

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Glen A. Lehman, MD · Indiana University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-09-30
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199679 on ClinicalTrials.gov