Implantable Systems Performance Registry (ISPR)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00959296

First received: August 13, 2009

Last updated: April 20, 2017

Last verified: April 2017

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.

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


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

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

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:	April 20, 2017

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 August 22, 2017

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