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

Medtronic

Status: Terminated

Conditions: Gastroesophageal Reflux Disease

Treatments: Device: Gatekeeper Reflux Repair System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00200044

MGU - 002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Diagnosis and main criteria for inclusion:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Gatekeeper Reflux Repair System

Treatment

Active Comparator group

Description:

The treatment arm has the Gatekeeper devices implanted.

Treatment:

Device: Gatekeeper Reflux Repair System