Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00959296
First received: August 13, 2009
Last updated: July 28, 2014
Last verified: July 2014

August 13, 2009
July 28, 2014
August 2003
August 2015   (final data collection date for primary outcome measure)
Product Performance [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Not Provided
Complete list of historical versions of study NCT00959296 on ClinicalTrials.gov Archive Site
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Implantable Systems Performance Registry
Implantable Systems Performance Registry

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Primary Care Clinic

  • Spinal Cord Stimulation
  • Deep Brain Stimulation
  • Drug Infusion (Implantable Pumps)
  • Sacral Nerve Stimulation
Device: 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.
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.
Intervention: Device: Various
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
11000
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August 2015   (final data collection date for primary outcome measure)

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
Both
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No
Contact: ISPR Team medtronicneurotrials@medtronic.com
United States,   Austria,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00959296
NSP0010-10000
No
MedtronicNeuro
MedtronicNeuro
Not Provided
Study Chair: ISPR Team Medtronic
MedtronicNeuro
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP