Back to results

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

Primary Purpose

Gastroesophageal Reflux Disease, Heartburn, Regurgitation

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mucosectomy

Rubber Band Ligation

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Endoscopic Mucosal Resection (EMR) Group

Banding Group

Arm Description

Outcomes

Primary Outcome Measures

Reduction of reflux symptoms measured by GERD HRQL

HRQL = Health Related Quality of Life Questionnaire

Secondary Outcome Measures

Reduction in total esophageal acid exposure measured by 48 hour pH monitoring

Full Information

NCT ID

NCT01199679

First Posted

September 9, 2010

Last Updated

June 17, 2015

Sponsor

Cook Group Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01199679

Brief Title

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

Acronym

GERD

Official Title

Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Study Start Date

June 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cook Group Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

Keywords

Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic Mucosal Resection (EMR) Group

Arm Type

Experimental

Arm Title

Banding Group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Mucosectomy

Intervention Description

Endoscopic mucosal resection in the upper GI tract.

Intervention Type

Procedure

Intervention Name(s)

Rubber Band Ligation

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction of reflux symptoms measured by GERD HRQL

Description

HRQL = Health Related Quality of Life Questionnaire

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Reduction in total esophageal acid exposure measured by 48 hour pH monitoring

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glen A. Lehman, MD

Organizational Affiliation

Indiana University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs