SCS MRI PMCF

• Research type

  Research Study

• Full title

  A Post-Market Study Evaluating the MR Conditional Neurostimulation Systems

• IRAS ID

  207366

• Contact name

  Ganesan Baranidharan

• Sponsor organisation

  SJM International, Inc.

• Clinicaltrials.gov Identifier

  NCT02738840

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  The propose of this post market clinical follow up study is the assessment (safety and functionality) of the St Jude Medical market-released Magnetic Resonance (MR) Conditional Neurostimulation Systems undergoing Magnetic Resonance Imaging (MRI). The subject population includes subjects who has been implanted with a commercially available SJM MR conditional neurostimulation system and who are scheduled to receive an MRI scan per patient's standard care. Subjects will be asked to return to the clinic 1-month follow-up visit after the MRI scan to confirm the device safety and functionality.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  16/YH/0255

• Date of REC Opinion

  13 Jul 2017

• REC opinion

  Further Information Favourable Opinion