Spinal Cord StimulationISPRNCT00959296
Implantable Systems Performance Registry
An observational study of Spinal Cord Stimulation and Deep Brain Stimulation, run by MedtronicNeuro at 50 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Stimulation, Deep Brain Stimulation, Drug Infusion (Implantable Pumps)
- What is being tested?
- Various
- Type of treatment
- Medical device
- How many people
- 10,981 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Aug 2003to 27 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator
Who cannot join
- 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
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
United States43 sites
Study site
Aliso Viejo, California
Study site
Annapolis, Maryland
Study site
Atlanta, Georgia
Study site
Bloomington, Illinois
Site recruiting for sacral nerve stimulation
Bradenton, Florida
Study site
Bremerton, Washington
Study site
Buffalo, New York
Study site
Chicago, Illinois
Site is recruiting for Deep Brain Stimulation
Cincinnati, Ohio
Study site
Evansville, Indiana
Study site
Gainesville, Georgia
Study site
Great Neck, New York
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Iowa City, Iowa
Study site
Los Angeles, California
Study site
Merritt Island, Florida
Study site
Minneapolis, Minnesota
Study site
Muncie, Indiana
Study site
Napa, California
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Ocala, Florida
Study site
Palm Springs, California
Study site
Pasadena, California
Study site
Poughkeepsie, New York
Study site
Roanoke, Virginia
Study site
Saint Paul, Minnesota
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
Silver Spring, Maryland
Study site
South Bend, Indiana
Study site
St Louis, Missouri
Study site
Tyler, Texas
Study site
Upland, California
Study site
Washington D.C., District of Columbia
Study site
West Chester, Ohio
Study site
West Des Moines, Iowa
Study site
Westminster, Maryland
Study site
Winston-Salem, North Carolina
Study site
York, Pennsylvania
About this study
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
- Being tested
- Various
- Keywords
- Registry, Pain, Chronic Pain, Back Pain, Intractable Spasticity, Parkinson's Disease, Essential Tremor, Dystonia, Implantable Pumps, Incontinence
- Medical subject headings
- Pain, Chronic Pain, Back Pain, Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VariousDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Various |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Performance
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2003
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,981 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ISPR Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959296
- Sponsor's protocol ID
- NSP0010-10000
- Acronym
- ISPR
- Status last verified
- Apr 2017
- First submitted
- 13 Aug 2009
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Systems Performance Registry
- ClinicalTrials.gov ID
- NCT00959296
- Acronym / sponsor ID
- ISPR / NSP0010-10000
- Conditions
- Spinal Cord Stimulation, Deep Brain Stimulation, Drug Infusion (Implantable Pumps), Sacral Neuromodulation
- Keywords
- Registry, Pain, Chronic Pain, Back Pain, Intractable Spasticity, Parkinson's Disease, Essential Tremor, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,981 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a device implant | – | Device: VariousPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VariousPatients 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 | Patients with a device implant |
Primary outcome
Product Performance
Time frame: Annually
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Related trials for Spinal Cord Stimulation
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AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
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Functional Electrical Stimulation Plus High Intensity Interval Training at Home
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Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Not yet recruiting
Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury
Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ISPR Team study chair
Medtronic
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Stimulation and Deep Brain Stimulation, run by MedtronicNeuro at 50 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Germany, Austria, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product Performance (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.