Implantable Systems Performance Registry

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.

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Key information

Conditions

Spinal Cord Stimulation Back Pain Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Pain Deep Brain Stimulation Drug Infusion (Implantable Pumps) Dyskinesias Dystonia Essential Tremor Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Sacral Neuromodulation Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Various

Device

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.

Primary outcomes

Product Performance

Time frame: Annually

To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Acronym: ISPR

Important dates

Study start: 2003
Primary completion: 2016
Study completion: 2016
First posted: Aug 14, 2009
Registry last updated: Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed