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

Abbott

Status: Completed

Conditions: Chronic Pain

Treatments: Procedure: MRI scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02738840

CRD_800

Details and patient eligibility

About

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

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Prodigy MRI or Proclaim Elite MR

Experimental group

Description:

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.

Treatment:

Procedure: MRI scan