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

NCT ID: NCT01199679

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Heartburn Regurgitation Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Endoscopic Mucosal Resection (EMR) Group

Group Type EXPERIMENTAL

Mucosectomy

Intervention Type PROCEDURE

Endoscopic mucosal resection in the upper GI tract.

Banding Group

Group Type EXPERIMENTAL

Rubber Band Ligation

Intervention Type PROCEDURE

Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Interventions

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Mucosectomy

Endoscopic mucosal resection in the upper GI tract.

Intervention Type PROCEDURE

Rubber Band Ligation

Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glen A. Lehman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Hospital

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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08-016

Identifier Type: -

Identifier Source: org_study_id

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