Implantable Systems Performance Registry

Completed

Conditions studied: Spinal Cord Stimulation, Deep Brain Stimulation, Drug Infusion (Implantable Pumps), Sacral Neuromodulation

In brief

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.

Key facts

Study ID

NCT00959296

Run by

MedtronicNeuro

People needed

10981

Starts

2003-08-01

Expected to finish

2016-09-27

Last updated by the study team

2017-04-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator

You may not qualify if…

• 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

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Aliso Viejo, California, United States
• Study site — Los Angeles, California, United States
• Study site — Napa, California, United States
• Study site — Palm Springs, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — Upland, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Site recruiting for sacral nerve stimulation — Bradenton, Florida, United States
• Study site — Merritt Island, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Gainesville, Georgia, United States
• Study site — Bloomington, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Muncie, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Annapolis, Maryland, United States
• Study site — Silver Spring, Maryland, United States
• Study site — Westminster, Maryland, United States

Full record on ClinicalTrials.gov

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