Clinical trial NCT00959296: Implantable Systems Performance Registry
Official title: Implantable Systems Performance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Stimulation
Deep Brain Stimulation
Drug Infusion (Implantable Pumps)
Sacral Neuromodulation
Keywords: Registry
Pain
Chronic Pain
Back Pain
Intractable Spasticity
Parkinson's Disease
Essential Tremor
Dystonia
Implantable Pumps
Incontinence
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 10981
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Product Performance
timeFrame: Annually
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Aliso Viejo
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: Upland
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Bradenton
country: United States
facility: Site recruiting for sacral nerve stimulation
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: West Des Moines
country: United States
state: Iowa
city: Annapolis
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Westminster
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
facility: Site is recruiting for Deep Brain Stimulation
state: Ohio
city: West Chester
country: United States
state: Ohio
city: York
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: Bremerton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Vienna
country: Austria
city: Montpellier
country: France
city: Cologne
country: Germany
city: Hannover
country: Germany
city: Pavia
country: Italy
city: Barcelona
country: Spain
city: Oxford
country: United Kingdom
Study officials:
affiliation: Medtronic
name: ISPR Team
role: STUDY_CHAIR
References: