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Implantable Systems Performance Registry (ISPR)

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ClinicalTrials.gov Identifier: NCT00959296
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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Brief Summary:

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

Study Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Product Performance [ Time Frame: Annually ]
    To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Chair: ISPR Team Medtronic
More Information
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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
Keywords provided by MedtronicNeuro:
Registry
Pain
Chronic Pain
Back Pain
Intractable Spasticity
 Parkinson's Disease
Essential Tremor
Dystonia
Implantable Pumps
Incontinence