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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00959296
Registration number
NCT00959296
Ethics application status
Date submitted
13/08/2009
Date registered
14/08/2009
Date last updated
21/04/2017
Titles & IDs
Public title
Implantable Systems Performance Registry
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Scientific title
Implantable Systems Performance Registry
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Secondary ID [1]
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NSP0010-10000
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Universal Trial Number (UTN)
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Trial acronym
ISPR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Stimulation
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Deep Brain Stimulation
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Drug Infusion (Implantable Pumps)
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Sacral Neuromodulation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Various
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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Product Performance
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Assessment method [1]
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To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
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Timepoint [1]
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Annually
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/09/2016
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Sample size
Target
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Accrual to date
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Final
10981
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Maryland
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Washington
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Austria
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Vienna
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France
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Montpellier
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Germany
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Cologne
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Germany
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Hannover
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Italy
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Pavia
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Spain
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Barcelona
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedtronicNeuro
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00959296
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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ISPR Team
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Address
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Medtronic
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00959296
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