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A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan | Procedure | MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month post MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful MRI Mode 'Turn on' Functionality | The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan. | Immediately before MRI Scan |
| Rate of Successful MRI Mode 'Turn Off' Functionality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Harbert | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Napa Valley Orthopedic Medical Group | Napa | California | 94558 | United States | ||
| Unity Spine Center |
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A total of 56 subjects were enrolled at 10 investigational sites in Europe and the United States (US). The first subject was enrolled on 21 October 2016 and the last subject on 22 September 2020. Completion of follow-up occurred on 02 December 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prodigy MRI or Proclaim Elite MR | 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. MRI scan: MRI scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional Spinal Cord Stimulator (SCS) system implanted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prodigy MRI or Proclaim Elite MR | 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. MRI scan: MRI scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | participants | 1 month post MRI scan |
|
|
1 month
No serious adverse events or procedure/device-related adverse events were reported in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prodigy MRI or Proclaim Elite MR | 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. MRI scan: MRI scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn A Capobianco | Abbott | +1 512 934 3941 | robyn.capobianco@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2019 | Apr 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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International, multicenter, prospective, and single-arm design
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The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | At 1-month follow-up |
| Rochester |
| New York |
| 14626 |
| United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Wilhelminenspital Wien | Vienna | 1160 | Austria |
| AZ Sint-Augustinus | Wilrijk | Belgium |
| Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf | Düsseldorf | Germany |
| Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera | Gera | Germany |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Hospital Virgen de Rocio | Seville | Spain |
| Seacroft Hospital | Leeds | Ykshre | LS14 6UH | United Kingdom |
| Subject Did not Meet Screening Inclusion/Exclusion Criteria |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IPG type | Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Rate of Successful MRI Mode 'Turn on' Functionality | The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately before MRI Scan |
|
|
|
| Secondary | Rate of Successful MRI Mode 'Turn Off' Functionality | The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately after MRI Scan |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately before MRI Scan |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately after MRI Scan |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 month follow-up |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately before MRI Scan |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately after MRI Scan |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At 1-month follow-up |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately before MRI Scan |
|
|
|
| Secondary | 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Immediately after MRI Scan |
|
|
|
| Secondary | 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At 1-month follow-up |
|
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
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| Successful download of subject's current program |
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