Implantable Systems Performance Registry

Deep Brain Stimulation Clinical Trial

— ISPR  

Official title:

Implantable Systems Performance Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959296
• Other study ID #: NSP0010-10000
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: April 20, 2017
• Start date: August 2003
• Est. completion date: September 27, 2016

Study information

• Verified date: April 2017
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10981
• Est. completion date: September 27, 2016
• Est. primary completion date: September 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Site recruiting for sacral nerve stimulation	Bradenton	Florida
United States	Site is recruiting for Deep Brain Stimulation	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Performance	To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices	Annually