Implantable Systems Performance Registry (ISPR)

April 20, 2017 updated by: MedtronicNeuro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10981

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • France
      • Montpellier, France
  • Germany
      • Cologne, Germany
      • Hannover, Germany
  • Italy
      • Pavia, Italy
  • Spain
      • Barcelona, Spain
  • United Kingdom
      • Oxford, United Kingdom
  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Aliso Viejo, California, United States
      • Los Angeles, California, United States
      • Napa, California, United States
      • Palm Springs, California, United States
      • Pasadena, California, United States
      • San Diego, California, United States
      • Upland, California, United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
        • Site recruiting for sacral nerve stimulation
      • Merritt Island, Florida, United States
      • Ocala, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Gainesville, Georgia, United States
    • Illinois
      • Bloomington, Illinois, United States
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Muncie, Indiana, United States
      • South Bend, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
      • West Des Moines, Iowa, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Silver Spring, Maryland, United States
      • Westminster, Maryland, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New York
      • Buffalo, New York, United States
      • Great Neck, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
        • Site is recruiting for Deep Brain Stimulation
      • West Chester, Ohio, United States
    • Pennsylvania
      • York, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Roanoke, Virginia, United States
    • Washington
      • Bremerton, Washington, United States
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product Performance
Time Frame: Annually
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Study Chair: ISPR Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

September 27, 2016

Study Completion (ACTUAL)

September 27, 2016

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (ESTIMATE)

August 14, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NSP0010-10000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Brain Stimulation

Clinical Trials on Various

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe