Post Approval Study of the remedē System



Status:Enrolling by invitation
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:3/15/2019
Start Date:June 28, 2018
End Date:May 2021

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Prospective, single arm cohort study to evaluate the long-term safety, long-term
effectiveness, and survival rate in subjects implanted with the remedē System.

This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate
the long-term safety, long-term effectiveness, and survival rate in subjects implanted with
the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and
actively being followed as part of the remedē System Pivotal Trial are eligible. An
individual subject's participation is expected to continue to five years post remedē System
implant.

Inclusion Criteria:

- Subjects who were previously implanted with the remedē System and participated in the
remedē System Pivotal Trial

- In the investigator's opinion, willing and able to comply with all study requirements

- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
informed consent (including Health Insurance Portability and Accountability Act
[HIPAA] authorization in the US)

Exclusion Criteria:

- There are no criteria by which a subject would be excluded
We found this trial at
18
sites
Saint Paul, Minnesota 55102
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Saint Paul, MN
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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Baltimore, MD
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Bad Oeynhausen, 32545
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Bad Oeynhausen,
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Cherry Hill, New Jersey 08034
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Cherry Hill, NJ
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Cincinnati, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Cordova, Tennessee 38018
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Cordova, TN
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Downers Grove, Illinois
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Downers Grove, IL
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Jacksonville, Florida 32209
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Jacksonville, FL
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Kansas City, MO
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Lincoln, Nebraska 68526
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Lincoln, NE
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Los Angeles, California 90033
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Los Angeles, CA
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Marshfield, Wisconsin 54449
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Marshfield, WI
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Antonio, Texas 78229
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San Antonio, TX
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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