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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MRI scan
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Napa Valley Orthopedic Medical Group
  • Unity Spine Center
  • Clinical Trials of South Carolina
  • Wilhelminenspital Wien
  • AZ Sint-Augustinus
  • Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
  • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
  • Azienda Ospedaliero Universitaria Pisana
  • Hospital Virgen de Rocio
  • Seacroft Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prodigy MRI or Proclaim Elite MR

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Successful MRI Mode 'Turn on' Functionality
The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Rate of Successful MRI Mode 'Turn Off' Functionality
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
April 11, 2016
Last Updated
May 26, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02738840
Brief Title
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Acronym
SCS MRI PMCF
Official Title
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
International, multicenter, prospective, and single-arm design
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prodigy MRI or Proclaim Elite MR
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Intervention Description
MRI scan
Primary Outcome Measure Information:
Title
The Rate of the MRI Scan-related Adverse Events
Description
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
Time Frame
1 month post MRI scan
Secondary Outcome Measure Information:
Title
Rate of Successful MRI Mode 'Turn on' Functionality
Description
The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Time Frame
Immediately before MRI Scan
Title
Rate of Successful MRI Mode 'Turn Off' Functionality
Description
The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
Time Frame
Immediately after MRI Scan
Title
Rate of Successful 'Turn Off' Functionality for the Stimulation
Description
The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.
Time Frame
Immediately before MRI Scan
Title
Rate of Successful 'Turn on' Functionality for the Stimulation
Description
The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.
Time Frame
Immediately after MRI Scan
Title
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Description
The rate of successful 'turn on/off' functionality for the stimulation at 1-month follow-up will be assessed.
Time Frame
At 1 month follow-up
Title
Rate of Successful Adjustments to the Program
Description
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Time Frame
Immediately before MRI Scan
Title
Rate of Successful Adjustments to the Program
Description
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Time Frame
Immediately after MRI Scan
Title
Rate of Successful Adjustments to the Program
Description
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Time Frame
At 1-month follow-up
Title
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Description
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.
Time Frame
Immediately before MRI Scan
Title
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Description
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
Time Frame
Immediately after MRI Scan
Title
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Description
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
Time Frame
At 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Harbert
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Napa Valley Orthopedic Medical Group
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Unity Spine Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Wilhelminenspital Wien
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
AZ Sint-Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
City
Dusseldorf
Country
Germany
Facility Name
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
City
Gera
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Hospital Virgen de Rocio
City
Sevilla
Country
Spain
Facility Name
Seacroft Hospital
City
Leeds
State/Province
Ykshre
ZIP/Postal Code
LS14 6UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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