Deep Brain Stimulation Clinical Trial
— ISPROfficial title:
Implantable Systems Performance Registry
Verified date | April 2017 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10981 |
Est. completion date | September 27, 2016 |
Est. primary completion date | September 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Site recruiting for sacral nerve stimulation | Bradenton | Florida |
United States | Site is recruiting for Deep Brain Stimulation | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro |
United States, Austria, France, Germany, Italy, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Product Performance | To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices | Annually |
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