A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

Conditions
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Chronic Pain

Intervention / Treatment
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* Procedure: MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: International, multicenter, prospective, and single-arm design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prodigy MRI or Proclaim Elite MR<br>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. | Procedure: MRI scan<br>* MRI scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |