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Completed

NCT Number: NCT02738840

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

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilhelminenspital Wien, Vienna, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scan

Procedure

MRI scan

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: SCS MRI PMCF

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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