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CompletedNCT02738840SCS MRI PMCFUpdated Jun 10, 2021Results posted

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

An interventional study of MRI scan in Chronic Pain, sponsored by Abbott Medical Devices. Completed at 10 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: MRI scan

Interventions

  • ProcedureMRI scan

    MRI scan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month post MRI scan

Secondary outcomes

  1. Rate of Successful MRI Mode 'Turn on' Functionality

    The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.

    Time frame: Immediately before MRI Scan

  2. Rate of Successful MRI Mode 'Turn Off' Functionality

    The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.

    Time frame: Immediately after MRI Scan

  3. 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.

    Time frame: Immediately before MRI Scan

  4. 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.

    Time frame: Immediately after MRI Scan

  5. 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.

    Time frame: At 1 month follow-up

  6. 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.

    Time frame: Immediately before MRI Scan

  7. 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.

    Time frame: Immediately after MRI Scan

  8. 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.

    Time frame: At 1-month follow-up

  9. 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.

    Time frame: Immediately before MRI Scan

  10. 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

    Time frame: Immediately after MRI Scan

  11. 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

    Time frame: At 1-month follow-up

07

Results

Posted May 24, 2021

Participant flow

A total of 56 subjects were enrolled at 10 investigational sites in Europe and the United States (US). The first subject was enrolled on 21 October 2016 and the last subject on 22 September 2020. Completion of follow-up occurred on 02 December 2020.

Participant flow — Overall Study
MilestoneProdigy MRI or Proclaim Elite MR
Started56
Completed48
Not completed8
Withdrew: Mri scan not performed5
Withdrew: Lost to follow-up1
Withdrew: Subject participation terminated by investigator1
Withdrew: Subject did not meet screening inclusion/exclusion criteria1

Outcome measures

PrimaryThe 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.

Time frame:
1 month post MRI scan
Reported as:
Number · participants
The Rate of the MRI Scan-related Adverse Events
participantsProdigy MRI or Proclaim Elite MR
The Rate of the MRI Scan-related Adverse Events0
SecondaryRate of Successful MRI Mode 'Turn on' Functionality

The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.

Time frame:
Immediately before MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful MRI Mode 'Turn on' Functionality
percentage of participantsProdigy MRI or Proclaim Elite MR
MRI Mode successfully turned on98.0 (89.55 to 99.95)
MRI Mode not successfully turned on2.0 (0.05 to 10.45)
SecondaryRate of Successful MRI Mode 'Turn Off' Functionality

The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.

Time frame:
Immediately after MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful MRI Mode 'Turn Off' Functionality
percentage of participantsProdigy MRI or Proclaim Elite MR
Rate of Successful MRI Mode 'Turn Off' Functionality100 (92.89 to 100.00)
SecondaryRate 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.

Time frame:
Immediately before MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful 'Turn Off' Functionality for the Stimulation
percentage of participantsProdigy MRI or Proclaim Elite MR
Rate of Successful 'Turn Off' Functionality for the Stimulation100 (88.06 to 100.00)
SecondaryRate 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.

Time frame:
Immediately after MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful 'Turn on' Functionality for the Stimulation
percentage of participantsProdigy MRI or Proclaim Elite MR
Rate of Successful 'Turn on' Functionality for the Stimulation100 (92.89 to 100.00)
SecondaryRate 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.

Time frame:
At 1 month follow-up
Reported as:
Number · percentage of participants
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
percentage of participantsProdigy MRI or Proclaim Elite MR
Stimulation successfully turned off100 (87.23 to 100.00)
Stimulation successfully turned on100 (87.23 to 100.00)
SecondaryRate 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.

Time frame:
Immediately before MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful Adjustments to the Program
percentage of participantsProdigy MRI or Proclaim Elite MR
Successful adjustments to stimulation amplitude100 (88.06 to 100.00)
Successful switch between stimulation programs100 (87.23 to 100.00)
SecondaryRate 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.

Time frame:
Immediately after MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful Adjustments to the Program
percentage of participantsProdigy MRI or Proclaim Elite MR
Successful adjustments to stimulation amplitude100 (87.66 to 100.00)
Successful switch between stimulation programs100 (85.75 to 100.00)
SecondaryRate 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.

Time frame:
At 1-month follow-up
Reported as:
Number · percentage of participants
Rate of Successful Adjustments to the Program
percentage of participantsProdigy MRI or Proclaim Elite MR
Successful adjustments to stimulation amplitude100 (87.23 to 100.00)
Successful switch between stimulation programs100 (87.23 to 100.00)
SecondaryRate 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.

Time frame:
Immediately before MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
percentage of participantsProdigy MRI or Proclaim Elite MR
Link successfully established with IPG or Patient Programmer100 (88.06 to 100.00)
Successful upload of subject's current program100 (88.06 to 100.00)
Successful download of subject's current program100 (88.06 to 100.00)
SecondaryRate 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

Time frame:
Immediately after MRI Scan
Reported as:
Number · percentage of participants
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
percentage of participantsProdigy MRI or Proclaim Elite MR
Link successfully established with IPG or Patient Programmer100 (87.66 to 100.00)
Successful upload of subject's current program100 (87.66 to 100.00)
Successful download of subject's current program100 (87.66 to 100.00)
SecondaryRate 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

Time frame:
At 1-month follow-up
Reported as:
Number · percentage of participants
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
percentage of participantsProdigy MRI or Proclaim Elite MR
Link successfully established with IPG or Patient Programmer100 (87.23 to 100.00)
Successful upload of subject's current program100 (86.28 to 100.00)
Successful download of subject's current program100 (86.28 to 100.00)

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prodigy MRI or Proclaim Elite MR0/55 (0%)0/55 (0%)0/55 (0%)

Baseline characteristics

Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional Spinal Cord Stimulator (SCS) system implanted.

Age, Continuous
Age, Continuous(years)Prodigy MRI or Proclaim Elite MR
Mean58.4 ± 14.4
Sex: Female, Male
Sex: Female, Male(Participants)Prodigy MRI or Proclaim Elite MR
Female36
Male19
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Prodigy MRI or Proclaim Elite MR
Region of Enrollment
Region of Enrollment(participants)Prodigy MRI or Proclaim Elite MR
Austria1
Belgium6
United States23
Italy8
United Kingdom5
Germany7
Spain6
IPG type
IPG type(Participants)Prodigy MRI or Proclaim Elite MR
Prodigy MRI26
Proclaim29
08

Study locations

10 sites
  • Napa Valley Orthopedic Medical Group
    Napa, California 94558, United States
  • Unity Spine Center
    Rochester, New York 14626, United States
  • Clinical Trials of South Carolina
    Charleston, South Carolina 29406, United States
  • Wilhelminenspital Wien
    Vienna, 1160, Austria
  • AZ Sint-Augustinus
    Wilrijk, Belgium
  • Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
    Dusseldorf, Germany
  • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
    Gera, Germany
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, 56126, Italy
  • Hospital Virgen de Rocio
    Sevilla, Spain
  • Seacroft Hospital
    Leeds, Ykshre LS14 6UH, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 25, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02738840
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Apr 14, 2016
Start date
Oct 21, 2016
Primary completion
Dec 2020
Completion
Dec 2, 2020
Results posted
May 24, 2021
Last update
Jun 10, 2021

Study contacts

Nicole Harbert
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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