Trials / Completed
CompletedNCT00959296
Implantable Systems Performance Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,981 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Spinal Cord Stimulation
- Deep Brain Stimulation
- Drug Infusion (Implantable Pumps)
- Sacral Neuromodulation
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2016-09-27
- Completion
- 2016-09-27
- First posted
- 2009-08-14
- Last updated
- 2017-04-21
Locations
50 sites across 7 countries: United States, Austria, France, Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00959296. Inclusion in this directory is not an endorsement.