Gatekeeper European 005

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

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Brief Summary

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Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04

Detailed Description

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Conditions

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GERD

Interventions

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Gatekeeper Reflux Repari System (Device)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
* Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent

Exclusion Criteria

* Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
* Developed other medical illness that may cause the subject to be non-compliant
* Extensive Barrett's Esophagus (\>2 cm)
* Unable or unwilling to cooperate with the study procedures

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medtronic GU Investigator

Role: PRINCIPAL_INVESTIGATOR

MedtronicNeuro

Locations

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Contact Medtronic for specific site information

Minneapolis, Minnesota, United States

Site Status

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Tolochenaz, , Switzerland