Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00959296




Registration number
NCT00959296
Ethics application status
Date submitted
13/08/2009
Date registered
14/08/2009
Date last updated
21/04/2017

Titles & IDs
Public title
Implantable Systems Performance Registry
Scientific title
Implantable Systems Performance Registry
Secondary ID [1] 0 0
NSP0010-10000
Universal Trial Number (UTN)
Trial acronym
ISPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Stimulation 0 0
Deep Brain Stimulation 0 0
Drug Infusion (Implantable Pumps) 0 0
Sacral Neuromodulation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Various

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Product Performance
Timepoint [1] 0 0
Annually

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2016
Sample size
Target
Accrual to date
Final
10981
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Vienna
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
Germany
State/province [24] 0 0
Cologne
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Italy
State/province [26] 0 0
Pavia
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedtronicNeuro
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00959296
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
ISPR Team
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries