Implantable Systems Performance Registry
ISPR
1 other identifier
observational
10,981
7 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2003
Longer than P75 for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2016
CompletedApril 21, 2017
April 1, 2017
13.2 years
August 13, 2009
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Product Performance
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Annually
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Primary Care Clinic
You may qualify if:
- Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (50)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Aliso Viejo, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Napa, California, United States
Unknown Facility
Palm Springs, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Site recruiting for sacral nerve stimulation
Bradenton, Florida, United States
Unknown Facility
Merritt Island, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Gainesville, Georgia, United States
Unknown Facility
Bloomington, Illinois, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Muncie, Indiana, United States
Unknown Facility
South Bend, Indiana, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
West Des Moines, Iowa, United States
Unknown Facility
Annapolis, Maryland, United States
Unknown Facility
Silver Spring, Maryland, United States
Unknown Facility
Westminster, Maryland, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Great Neck, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Poughkeepsie, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Site is recruiting for Deep Brain Stimulation
Cincinnati, Ohio, United States
Unknown Facility
West Chester, Ohio, United States
Unknown Facility
York, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Tyler, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Roanoke, Virginia, United States
Unknown Facility
Bremerton, Washington, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Vienna, Austria
Unknown Facility
Montpellier, France
Unknown Facility
Cologne, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Pavia, Italy
Unknown Facility
Barcelona, Spain
Unknown Facility
Oxford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ISPR Team
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
August 1, 2003
Primary Completion
September 27, 2016
Study Completion
September 27, 2016
Last Updated
April 21, 2017
Record last verified: 2017-04