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An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)

NCT00200044 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2009-07-13

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DEVICE

Gatekeeper Reflux Repair System

The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score \>15.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Glen Lehman · 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
2002-12-31
Primary Completion
2006-06-30
Completion
2008-06-30

Countries

  • United States
  • Netherlands

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 NCT00200044 on ClinicalTrials.gov