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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-21

Study Completion Date

2020-12-02

Brief Summary

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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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Detailed Description

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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).

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

International, multicenter, prospective, and single-arm design

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI scan

Intervention Type PROCEDURE

MRI scan

Interventions

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MRI scan

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No