Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00959296
First received: August 13, 2009
Last updated: July 28, 2014
Last verified: July 2014
  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.


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

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

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

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


Estimated Enrollment: 11000
Study Start Date: August 2003
Estimated Primary Completion Date: August 2015 (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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959296

Contacts
Contact: ISPR Team medtronicneurotrials@medtronic.com

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

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00959296     History of Changes
Other Study ID Numbers: NSP0010-10000
Study First Received: August 13, 2009
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
Registry
Pain
Chronic Pain
Back Pain
Intractable Spasticity
Parkinson's Disease
Essential Tremor
Dystonia
Implantable Pumps
Incontinence

ClinicalTrials.gov processed this record on September 29, 2014