ISPR: Implantable Systems Performance Registry

Sponsor

MedtronicNeuro (Industry)

Overall Status

Completed

CT.gov ID

NCT00959296

Collaborator

(none)

10,981

Enrollment

Locations

157.9

Duration (Months)

219.6

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Stimulation Deep Brain Stimulation Drug Infusion (Implantable Pumps) Sacral Neuromodulation	Device: Various

Study Design

Study Type:

Observational

Actual Enrollment :

10981 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Implantable Systems Performance Registry

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Sep 27, 2016

Actual Study Completion Date :

Sep 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
Patients with a device implant 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.	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.

Arm

Intervention/Treatment

Patients with a device implant

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1		Huntsville	Alabama	United States
2		Scottsdale	Arizona	United States
3		Aliso Viejo	California	United States
4		Los Angeles	California	United States
5		Napa	California	United States
6		Palm Springs	California	United States
7		Pasadena	California	United States
8		San Diego	California	United States
9		Upland	California	United States
10		Washington, D.C.	District of Columbia	United States
11	Site recruiting for sacral nerve stimulation	Bradenton	Florida	United States
12		Merritt Island	Florida	United States
13		Ocala	Florida	United States
14		Atlanta	Georgia	United States
15		Gainesville	Georgia	United States
16		Bloomington	Illinois	United States
17		Chicago	Illinois	United States
18		Evansville	Indiana	United States
19		Muncie	Indiana	United States
20		South Bend	Indiana	United States
21		Iowa City	Iowa	United States
22		West Des Moines	Iowa	United States
23		Annapolis	Maryland	United States
24		Silver Spring	Maryland	United States
25		Westminster	Maryland	United States
26		Minneapolis	Minnesota	United States
27		Saint Paul	Minnesota	United States
28		Saint Louis	Missouri	United States
29		Buffalo	New York	United States
30		Great Neck	New York	United States
31		New York	New York	United States
32		Poughkeepsie	New York	United States
33		Winston-Salem	North Carolina	United States
34	Site is recruiting for Deep Brain Stimulation	Cincinnati	Ohio	United States
35		West Chester	Ohio	United States
36		York	Pennsylvania	United States
37		Nashville	Tennessee	United States
38		Houston	Texas	United States
39		Tyler	Texas	United States
40		Salt Lake City	Utah	United States
41		Roanoke	Virginia	United States
42		Bremerton	Washington	United States
43		Seattle	Washington	United States
44		Vienna		Austria
45		Montpellier		France
46		Cologne		Germany
47		Hannover		Germany
48		Pavia		Italy
49		Barcelona		Spain
50		Oxford		United Kingdom