NCT02738840CompletedNot Applicable
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Abbott Medical Devices18 sites in 7 countries56 target enrollmentStarted: October 21, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 56
- Locations
- 18
- Primary Endpoint
- The Rate of the MRI Scan-related Adverse Events
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rate of Successful 'Turn on/Off' Functionality for the Stimulation(At 1 month follow-up)
- Rate of Successful Adjustments to the Program(At 1-month follow-up)
- Rate of Successful 'Turn on' Functionality for the Stimulation(Immediately after MRI Scan)
- Rate of Successful MRI Mode 'Turn Off' Functionality(Immediately after MRI Scan)
- Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters(Immediately before MRI Scan)
- Rate of Successful MRI Mode 'Turn on' Functionality(Immediately before MRI Scan)
- Rate of Successful 'Turn Off' Functionality for the Stimulation(Immediately before MRI Scan)
- Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters(At 1-month follow-up)
Investigators
Study Sites (18)
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