Implantable Systems Performance Registry (ISPR)
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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. |
ClinicalTrials.gov Identifier: NCT00959296 |
Recruitment Status :
Completed
First Posted : August 14, 2009
Last Update Posted : April 21, 2017
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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.
Condition or disease | Intervention/treatment |
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Spinal Cord Stimulation Deep Brain Stimulation Drug Infusion (Implantable Pumps) Sacral Neuromodulation | Device: Various |
Study Type : | Observational |
Actual Enrollment : | 10981 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Implantable Systems Performance Registry |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | September 27, 2016 |
Actual Study Completion Date : | September 27, 2016 |

Group/Cohort | Intervention/treatment |
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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.
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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. |
- Product Performance [ Time Frame: Annually ]To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959296

Study Chair: | ISPR Team | Medtronic |
Responsible Party: | MedtronicNeuro |
ClinicalTrials.gov Identifier: | NCT00959296 |
Other Study ID Numbers: |
NSP0010-10000 |
First Posted: | August 14, 2009 Key Record Dates |
Last Update Posted: | April 21, 2017 |
Last Verified: | April 2017 |
Registry Pain Chronic Pain Back Pain Intractable Spasticity |
Parkinson's Disease Essential Tremor Dystonia Implantable Pumps Incontinence |