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Implantable Systems Performance Registry (ISPR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959296
First Posted: August 14, 2009
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedtronicNeuro
August 13, 2009
August 14, 2009
April 21, 2017
August 2003
September 27, 2016   (Final data collection date for primary outcome measure)
Product Performance [ Time Frame: Annually ]
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
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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.

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.

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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 Neuromodulation
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10981
September 27, 2016
September 27, 2016   (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00959296
NSP0010-10000
No
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MedtronicNeuro
MedtronicNeuro
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Study Chair: ISPR Team Medtronic
MedtronicNeuro
April 2017