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

Overview

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

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).

Interventions

  • Procedure: MRI scan
    • MRI scan

Arms, Groups and Cohorts

  • Experimental: Prodigy MRI or Proclaim Elite MR
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Rate of Successful MRI Mode ‘Turn on’ Functionality
    • Time Frame: Immediately before MRI Scan
    • The rate of successful MRI mode ‘turn on’ functionality will be assessed during pre-MRI scan.
  • Rate of Successful MRI Mode ‘Turn Off’ Functionality
    • Time Frame: Immediately after MRI Scan
    • The rate of successful MRI mode ‘turn off’ functionality will be assessed during Post-MRI Scan.
  • Rate of Successful ‘Turn Off’ Functionality for the Stimulation
    • Time Frame: Immediately before MRI Scan
    • The rate of successful ‘turn off’ functionality for the stimulation will be assessed immediately before MRI Scan.
  • Rate of Successful ‘Turn on’ Functionality for the Stimulation
    • Time Frame: Immediately after MRI Scan
    • The rate of successful ‘turn on’ functionality for the stimulation will be assessed immediately after MRI Scan.
  • Rate of Successful ‘Turn on/Off’ Functionality for the Stimulation
    • Time Frame: At 1 month follow-up
    • The rate of successful ‘turn on/off’ functionality for the stimulation at 1-month follow-up will be assessed.
  • Rate of Successful Adjustments to the Program
    • Time Frame: Immediately before MRI Scan
    • The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
  • Rate of Successful Adjustments to the Program
    • Time Frame: Immediately after MRI Scan
    • The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
  • Rate of Successful Adjustments to the Program
    • Time Frame: At 1-month follow-up
    • The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
  • Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
    • Time Frame: Immediately before MRI Scan
    • 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.
  • Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
    • Time Frame: Immediately after MRI Scan
    • 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
  • Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
    • Time Frame: At 1-month follow-up
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicole Harbert, Study Director, Abbott

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