Chronic PainSCS MRI PMCFNCT02738840
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
A study testing MRI scan in people with Chronic Pain, run by Abbott Medical Devices at 10 sites in 7 countries.
Trial summary
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MRI scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 21 Oct 2016to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
- Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
- Patient is ≥ 18 years of age
- Patient must be willing and able to comply with study requirements
- Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Who cannot join
- Patient has another implanted device (active or passive) that prohibits safe scanning
- Patient has previously experienced an MRI scan-related adverse event
- Patient is currently enrolled in another Abbott study that collects MRI safety data
- Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
United States3 sites
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Napa Valley Orthopedic Medical Group
Napa, California, 94558
Unity Spine Center
Rochester, New York, 14626
Germany2 sites
Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
Düsseldorf
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
Gera
About this study
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
Read the detailed description
The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).
- Conditions
- Chronic Pain
- Being tested
- MRI scan
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanProcedure or surgery
MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Prodigy MRI or Proclaim Elite MR | Experimental | The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).
The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part. Receives: Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of the MRI Scan-related Adverse Events
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
Measured: 1 month post MRI scan
Secondary outcomes (11)
Rate of Successful MRI Mode 'Turn on' Functionality
The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Measured: Immediately before MRI Scan
Rate of Successful MRI Mode 'Turn Off' Functionality
The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
Measured: Immediately after MRI Scan
Rate of Successful 'Turn Off' Functionality for the Stimulation
The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.
Measured: Immediately before MRI Scan
Rate of Successful 'Turn on' Functionality for the Stimulation
The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.
Measured: Immediately after MRI Scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
The rate of successful 'turn on/off' functionality for the stimulation at 1-month follow-up will be assessed.
Measured: At 1 month follow-up
Rate of Successful Adjustments to the Program
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Measured: Immediately before MRI Scan
Rate of Successful Adjustments to the Program
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Measured: Immediately after MRI Scan
Rate of Successful Adjustments to the Program
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Measured: At 1-month follow-up
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
The rate of interrogations and uploads/downloads of the IPG parameters will be assessed immediately before MRI Scan. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program.
Measured: Immediately before MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
The rate of interrogations and uploads/downloads of the IPG parameters will be assessed immediately after MRI Scan. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program
Measured: Immediately after MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
The rate of interrogations and uploads/downloads of the IPG parameters will be assessed at 1-month follow-up. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program
Measured: At 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start21 Oct 2016
- Primary completionDec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- International, multicenter, prospective, and single-arm design
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Harbert, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738840
- Sponsor's protocol ID
- CRD_800
- Acronym
- SCS MRI PMCF
- Status last verified
- May 2021
- First submitted
- 11 Apr 2016
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
- ClinicalTrials.gov ID
- NCT02738840
- Acronym / sponsor ID
- SCS MRI PMCF / CRD_800
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
Detailed description
The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- International, multicenter, prospective, and single-arm design
| Arm | Type | Receives |
|---|---|---|
| Prodigy MRI or Proclaim Elite MR | Experimental | Procedure: MRI scanThe Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip). The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
- Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
- Patient is ≥ 18 years of age
- Patient must be willing and able to comply with study requirements
- Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Key exclusion criteria (4 listed)
- Patient has another implanted device (active or passive) that prohibits safe scanning
- Patient has previously experienced an MRI scan-related adverse event
- Patient is currently enrolled in another Abbott study that collects MRI safety data
- Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding
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 |
|---|---|---|
| MRI scanMRI scan | Procedure or surgery | Prodigy MRI or Proclaim Elite MR |
Primary outcome
The Rate of the MRI Scan-related Adverse Events
Time frame: 1 month post MRI scan
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
11 secondary outcomes
Rate of Successful MRI Mode 'Turn on' Functionality
Time frame: Immediately before MRI Scan
Rate of Successful MRI Mode 'Turn Off' Functionality
Time frame: Immediately after MRI Scan
Rate of Successful 'Turn Off' Functionality for the Stimulation
Time frame: Immediately before MRI Scan
Rate of Successful 'Turn on' Functionality for the Stimulation
Time frame: Immediately after MRI Scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Time frame: At 1 month follow-up
Rate of Successful Adjustments to the Program
Time frame: Immediately before MRI Scan
Rate of Successful Adjustments to the Program
Time frame: Immediately after MRI Scan
Rate of Successful Adjustments to the Program
Time frame: At 1-month follow-up
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Time frame: Immediately before MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Time frame: Immediately after MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Time frame: At 1-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nicole Harbert study director
Abbott
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Chronic Pain, run by Abbott Medical Devices at 10 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 5 inclusion and 4 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany, Austria, Belgium, 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?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Rate of the MRI Scan-related Adverse Events (time frame: 1 month post MRI scan). 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 10 Jun 2021.