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Implantable Systems Performance Registry (ISPR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959296
First Posted: August 14, 2009
Last Update Posted: April 21, 2017
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.
Information provided by (Responsible Party):
MedtronicNeuro
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implantable Systems Performance Registry

Further study details as provided by MedtronicNeuro:

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


Enrollment: 10981
Study Start Date: August 2003
Study Completion Date: September 27, 2016
Primary Completion Date: September 27, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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


  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, California
Aliso Viejo, California, United States
Los Angeles, California, United States
Napa, California, United States
Palm Springs, California, United States
Pasadena, California, United States
San Diego, California, United States
Upland, California, United States
United States, District of Columbia
Washington, D.C., District of Columbia, United States
United States, Florida
Site recruiting for sacral nerve stimulation
Bradenton, Florida, United States
Merritt Island, Florida, United States
Ocala, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Gainesville, Georgia, United States
United States, Illinois
Bloomington, Illinois, United States
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Muncie, Indiana, United States
South Bend, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
West Des Moines, Iowa, United States
United States, Maryland
Annapolis, Maryland, United States
Silver Spring, Maryland, United States
Westminster, Maryland, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New York
Buffalo, New York, United States
Great Neck, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Site is recruiting for Deep Brain Stimulation
Cincinnati, Ohio, United States
West Chester, Ohio, United States
United States, Pennsylvania
York, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Tyler, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Roanoke, Virginia, United States
United States, Washington
Bremerton, Washington, United States
Seattle, Washington, United States
Austria
Vienna, Austria
France
Montpellier, France
Germany
Cologne, Germany
Hannover, Germany
Italy
Pavia, Italy
Spain
Barcelona, Spain
United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Chair: ISPR Team Medtronic
  More Information

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00959296     History of Changes
Other Study ID Numbers: NSP0010-10000
First Submitted: August 13, 2009
First Posted: August 14, 2009
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