Implantable Systems Performance Registry (ISPR)

This study is currently recruiting participants.

Verified January 2013 by MedtronicNeuro

Sponsor:

Information provided by (Responsible Party):

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00959296

First received: August 13, 2009

Last updated: January 16, 2013

Last verified: January 2013

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 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:

Genetics Home Reference related topics: dopa-responsive dystonia essential tremor Parkinson disease

U.S. FDA Resources

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

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
	Active, not recruiting
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
	Recruiting
Bradenton, Florida, United States
	Recruiting
Merritt Island, Florida, United States
	Recruiting
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
	Active, not recruiting
Great Neck, New York, United States
	Recruiting
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
	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
	Recruiting
Vienna, Austria
France
	Recruiting
Montpellier, France
Germany
	Recruiting
Cologne, Germany
	Recruiting
Hannover, Germany
Italy
	Recruiting
Pavia, Italy
Spain
	Recruiting
Barcelona, Spain
United Kingdom
	Recruiting
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:	January 16, 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 May 16, 2013

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