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

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Procedure: MRI scan

Registration Number: NCT02738840

Lead Sponsor: Abbott Medical Devices

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

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prodigy MRI or Proclaim Elite MR	MRI scan	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.

Primary Outcome Measures

Name	Time	Method
The Rate of the MRI Scan-related Adverse Events	1 month post MRI scan	The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	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	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 'Turn on' Functionality for the Stimulation	Immediately after MRI Scan	The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.
Rate of Successful MRI Mode 'Turn Off' Functionality	Immediately after MRI Scan	The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters	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 MRI Mode 'Turn on' Functionality	Immediately before MRI Scan	The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Rate of Successful 'Turn Off' Functionality for the Stimulation	Immediately before MRI Scan	The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters	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

Trial Locations

Locations (10): Napa Valley Orthopedic Medical Group
🇺🇸
Napa, California, United States
Wilhelminenspital Wien
🇦🇹
Vienna, Austria
Unity Spine Center
🇺🇸
Rochester, New York, United States
AZ Sint-Augustinus
🇧🇪
Wilrijk, Belgium
Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
🇩🇪
Dusseldorf, Germany
Seacroft Hospital
🇬🇧
Leeds, Ykshre, United Kingdom
Azienda Ospedaliero Universitaria Pisana
🇮🇹
Pisa, Italy
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
🇩🇪
Gera, Germany
Hospital Virgen de Rocio
🇪🇸
Sevilla, Spain
Clinical Trials of South Carolina
🇺🇸
Charleston, South Carolina, United States