Implantable Systems Performance Registry (ISPR)

Medtronic

Status: Completed

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

Treatments: Device: Various

Study type: Observational

Funder types: Industry

Identifiers

NCT00959296

NSP0010-10000

Details and patient eligibility

About

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.

Enrollment: 10,981 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

10,981 participants in 1 patient group

Patients with a device implant

Description:

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.

Treatment:

Device: Various