Implantable Systems Performance Registry

Completed

• Conditions: Sacral Neuromodulation; Drug Infusion (Implantable Pumps); Spinal Cord Stimulation; Deep Brain Stimulation

• Registration Number: NCT00959296
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2016-09-27
• Study Completion: 2016-09-27
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10981

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Product Performance	Annually	To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices

Trial Locations

Locations (2)

Site recruiting for sacral nerve stimulation; 🇺🇸 Bradenton, Florida, United States

Site is recruiting for Deep Brain Stimulation; 🇺🇸 Cincinnati, Ohio, United States