N/A
Completed N=56
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Source: ClinicalTrials.gov NCT02738840 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: The Rate of the MRI Scan-related Adverse Events — 0 participants
Summary
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of the MRI Scan-related Adverse Events |
— | — |
| SECONDARY Rate of Successful MRI Mode 'Turn on' Functionality |
98.0; 2.0 | — |
| SECONDARY Rate of Successful MRI Mode 'Turn Off' Functionality |
100 | — |
| SECONDARY Rate of Successful 'Turn Off' Functionality for the Stimulation |
100 | — |
| SECONDARY Rate of Successful 'Turn on' Functionality for the Stimulation |
100 | — |
| SECONDARY Rate of Successful 'Turn on/Off' Functionality for the Stimulation |
100; 100 | — |
| SECONDARY Rate of Successful Adjustments to the Program |
100; 100 | — |
| SECONDARY Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters |
100; 100; 100 | — |
| SECONDARY Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters |
100; 100; 100 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02738840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.