Implantable Systems Performance Registry

NCT ID: NCT00959296

Last Updated: 2017-04-21

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

COMPLETED

Total Enrollment

10981 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2016-09-27

Brief Summary

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The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.

Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.

Detailed Description

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Conditions

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Spinal Cord Stimulation Deep Brain Stimulation Drug Infusion (Implantable Pumps) Sacral Neuromodulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with a device implant

Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator.

Various

Intervention Type DEVICE

Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator.

Interventions

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Various

Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator

Exclusion Criteria

* Patient who is or will be inaccessible for follow-up at an ISPR study site
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedtronicNeuro

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ISPR Team

Role: STUDY_CHAIR

Medtronic

Locations

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Huntsville, Alabama, United States

Site Status

Scottsdale, Arizona, United States

Site Status

Aliso Viejo, California, United States

Site Status

Los Angeles, California, United States

Site Status

Napa, California, United States

Site Status

Palm Springs, California, United States

Site Status

Pasadena, California, United States

Site Status

San Diego, California, United States

Site Status

Upland, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Site recruiting for sacral nerve stimulation

Bradenton, Florida, United States

Site Status

Merritt Island, Florida, United States

Site Status

Ocala, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Gainesville, Georgia, United States

Site Status

Bloomington, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Evansville, Indiana, United States

Site Status

Muncie, Indiana, United States

Site Status

South Bend, Indiana, United States

Site Status

Iowa City, Iowa, United States

Site Status

West Des Moines, Iowa, United States

Site Status

Annapolis, Maryland, United States

Site Status

Silver Spring, Maryland, United States

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Westminster, Maryland, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Buffalo, New York, United States

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Great Neck, New York, United States

Site Status

New York, New York, United States

Site Status

Poughkeepsie, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Site is recruiting for Deep Brain Stimulation

Cincinnati, Ohio, United States

Site Status

West Chester, Ohio, United States

Site Status

York, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Roanoke, Virginia, United States

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Bremerton, Washington, United States

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Seattle, Washington, United States

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Vienna, , Austria

Site Status

Montpellier, , France

Site Status

Cologne, , Germany

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Hanover, , Germany

Site Status

Pavia, , Italy

Site Status

Barcelona, , Spain

Site Status

Oxford, , United Kingdom

Site Status

Countries

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United States Austria France Germany Italy Spain United Kingdom

Other Identifiers

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NSP0010-10000

Identifier Type: -

Identifier Source: org_study_id

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