A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling
Study Title
A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling
Purpose
This study will support the claim that MRI procedures are safe when performed according to the approved guidance.
Eligibility
Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
Subject is scheduled to undergo a MRI procedure
You Cannot
Have another implanted device (active or passive implanted device) that prohibits safe scanning.
Have previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason
Study Process
Patients will undergo standard of care MRI as scheduled. The Infinity device will be interrogated before and after the procedure. A 30 day follow-up will be scheduled at which time the device will be interrogated
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Trial Details
Investigator:
Dr. Jessica Wilden, M.D.
IRB:
Willis-Knighton
IRB Number:
19.0002
Trial Type:
NA
Sponsor:
Abbott
Contact Information: