Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00959296
First received: August 13, 2009
Last updated: May 20, 2014
Last verified: May 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:

Estimated Enrollment: 10300
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
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

  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: May 20, 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 July 13, 2014