Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

143

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach

2 countries

11 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Start

First participant enrolled

December 1, 2002

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed

Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

July 10, 2009

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

Reduction in serious device and procedure related adverse device effects.
6 months

Secondary Outcomes (1)

Improvement in espophageal pH
6 months

Study Arms (2)

Sham

SHAM COMPARATOR

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.

Device: Gatekeeper Reflux Repair System

Treatment

ACTIVE COMPARATOR

The treatment arm has the Gatekeeper devices implanted.

Device: Gatekeeper Reflux Repair System

Interventions

Gatekeeper Reflux Repair SystemDEVICE

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.

Also known as: Gatekeeper

ShamTreatment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.