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Implantable Systems Performance Registry (ISPR)

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
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Tracking Information
First Submitted Date August 13, 2009
First Posted Date August 14, 2009
Last Update Posted Date April 21, 2017
Study Start Date August 2003
Actual Primary Completion Date September 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2014)
Product Performance [ Time Frame: Annually ]
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Implantable Systems Performance Registry
Official Title Implantable Systems Performance Registry
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary Care Clinic
Condition
  • Spinal Cord Stimulation
  • Deep Brain Stimulation
  • Drug Infusion (Implantable Pumps)
  • Sacral Neuromodulation
Intervention 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.
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 20, 2017)
10981
Original Estimated Enrollment
 (submitted: August 13, 2009)
10000
Actual Study Completion Date September 27, 2016
Actual Primary Completion Date September 27, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00959296
Other Study ID Numbers NSP0010-10000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MedtronicNeuro
Study Sponsor MedtronicNeuro
Collaborators Not Provided
Investigators
Study Chair: ISPR Team Medtronic
PRS Account MedtronicNeuro
Verification Date April 2017