Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2016 by MedtronicNeuro

Sponsor:

Information provided by (Responsible Party):

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00959296

First received: August 13, 2009

Last updated: June 24, 2016

Last verified: June 2016

History of Changes

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 Neuromodulation	Device: Various


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

Resource links provided by NLM:

Genetics Home Reference related topics: essential tremor

U.S. FDA Resources

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:	11500
Study Start Date:	August 2003
Estimated Primary Completion Date:	October 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


Ages Eligible for Study:	Child, Adult, Senior
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 50 Study Locations

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
Study First Received:	August 13, 2009
Last Updated:	June 24, 2016
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 26, 2016

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