Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants.
Verified November 2013 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00959296
First received: August 13, 2009
Last updated: November 14, 2013
Last verified: November 2013
  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:

Estimated Enrollment: 10000
Study Start Date: August 2003
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959296

Contacts
Contact: ISPR Team medtronicneurotrials@medtronic.com

  Show 49 Study Locations
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: November 14, 2013
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 April 14, 2014