Trial Outcomes & Findings for A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems (NCT NCT02738840)
NCT ID: NCT02738840
Last Updated: 2021-06-10
Results Overview
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
COMPLETED
NA
56 participants
1 month post MRI scan
2021-06-10
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 milestones
| Measure |
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.
MRI scan: MRI scan
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
MRI scan: MRI scan
|
|---|---|
|
Overall Study
MRI Scan not Performed
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Subject Participation Terminated by Investigator
|
1
|
|
Overall Study
Subject Did not Meet Screening Inclusion/Exclusion Criteria
|
1
|
Baseline Characteristics
Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
Baseline characteristics by cohort
| Measure |
Prodigy MRI or Proclaim Elite MR
n=56 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 14.4 • n=55 Participants • Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
|
|
Sex: Female, Male
Female
|
36 Participants
n=55 Participants • Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
|
|
Sex: Female, Male
Male
|
19 Participants
n=55 Participants • Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
|
|
Region of Enrollment
Austria
|
1 participants
n=56 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=56 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=56 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=56 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=56 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=56 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=56 Participants
|
|
IPG type
Prodigy MRI
|
26 Participants
n=55 Participants • Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
|
|
IPG type
Proclaim
|
29 Participants
n=55 Participants • Of the 56 enrolled subjects, 55 subjects completed the baseline visit; one subject did not have an MR conditional SCS system implanted.
|
PRIMARY outcome
Timeframe: 1 month post MRI scanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=50 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
The Rate of the MRI Scan-related Adverse Events
|
0 participants
|
SECONDARY outcome
Timeframe: Immediately before MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=51 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful MRI Mode 'Turn on' Functionality
MRI Mode successfully turned on
|
98.0 percentage of participants
Interval 89.55 to 99.95
|
|
Rate of Successful MRI Mode 'Turn on' Functionality
MRI Mode not successfully turned on
|
2.0 percentage of participants
Interval 0.05 to 10.45
|
SECONDARY outcome
Timeframe: Immediately after MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=50 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful MRI Mode 'Turn Off' Functionality
|
100 percentage of participants
Interval 92.89 to 100.0
|
SECONDARY outcome
Timeframe: Immediately before MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful 'Turn Off' Functionality for the Stimulation
|
100 percentage of participants
Interval 88.06 to 100.0
|
SECONDARY outcome
Timeframe: Immediately after MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=50 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful 'Turn on' Functionality for the Stimulation
|
100 percentage of participants
Interval 92.89 to 100.0
|
SECONDARY outcome
Timeframe: At 1 month follow-upPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful 'turn on/off' functionality for the stimulation at 1-month follow-up will be assessed.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=27 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Stimulation successfully turned off
|
100 percentage of participants
Interval 87.23 to 100.0
|
|
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Stimulation successfully turned on
|
100 percentage of participants
Interval 87.23 to 100.0
|
SECONDARY outcome
Timeframe: Immediately before MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Adjustments to the Program
Successful adjustments to stimulation amplitude
|
100 percentage of participants
Interval 88.06 to 100.0
|
|
Rate of Successful Adjustments to the Program
Successful switch between stimulation programs
|
100 percentage of participants
Interval 87.23 to 100.0
|
SECONDARY outcome
Timeframe: Immediately after MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Adjustments to the Program
Successful adjustments to stimulation amplitude
|
100 percentage of participants
Interval 87.66 to 100.0
|
|
Rate of Successful Adjustments to the Program
Successful switch between stimulation programs
|
100 percentage of participants
Interval 85.75 to 100.0
|
SECONDARY outcome
Timeframe: At 1-month follow-upPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Adjustments to the Program
Successful switch between stimulation programs
|
100 percentage of participants
Interval 87.23 to 100.0
|
|
Rate of Successful Adjustments to the Program
Successful adjustments to stimulation amplitude
|
100 percentage of participants
Interval 87.23 to 100.0
|
SECONDARY outcome
Timeframe: Immediately before MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
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.
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Link successfully established with IPG or Patient Programmer
|
100 percentage of participants
Interval 88.06 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Successful upload of subject's current program
|
100 percentage of participants
Interval 88.06 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Successful download of subject's current program
|
100 percentage of participants
Interval 88.06 to 100.0
|
SECONDARY outcome
Timeframe: Immediately after MRI ScanPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
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
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=28 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Link successfully established with IPG or Patient Programmer
|
100 percentage of participants
Interval 87.66 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Successful upload of subject's current program
|
100 percentage of participants
Interval 87.66 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Successful download of subject's current program
|
100 percentage of participants
Interval 87.66 to 100.0
|
SECONDARY outcome
Timeframe: At 1-month follow-upPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
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
Outcome measures
| Measure |
Prodigy MRI or Proclaim Elite MR
n=29 Participants
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.
MRI scan: MRI scan
|
|---|---|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Link successfully established with IPG or Patient Programmer
|
100 percentage of participants
Interval 87.23 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Successful upload of subject's current program
|
100 percentage of participants
Interval 86.28 to 100.0
|
|
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Successful download of subject's current program
|
100 percentage of participants
Interval 86.28 to 100.0
|
Adverse Events
Prodigy MRI or Proclaim Elite MR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER