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

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

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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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

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Gastroesophageal Reflux Disease

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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Sham

This arm of the study has the procedure but does not get the Gatekeeper prostheses. The Sham arm has the option to cross-over to the Treatment arm at the 6-month visit.

Group Type SHAM_COMPARATOR

Gatekeeper Reflux Repair System

Intervention Type DEVICE

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.

Treatment

The treatment arm has the Gatekeeper devices implanted.

Group Type ACTIVE_COMPARATOR

Gatekeeper Reflux Repair System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Gatekeeper

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with GERD with symptomatic improvement on PPIs.
* Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0.
* Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.

Diagnosis and main criteria for exclusion:

* Extensive Barrett's Esophagus (\> 2 cm).
* Esophagitis (LA Classification Grades C or D).
* Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer.
* Large hiatal hernia (\> 3 cm).
* Current complaints of clinical dysphagia evidenced by greater than one occurrence per month.
* Esophageal strictures
* Esophageal or gastric varices

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No