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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02738840

Acronym

SCS MRI PMCF

Enrollment

Registered

2016-04-14

Start date

2016-10-21

Completion date

2020-12-02

Last updated

2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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).

Interventions

PROCEDUREMRI scan

MRI scan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

International, multicenter, prospective, and single-arm design

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 '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 '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 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 Adjustments to the Program	Immediately before MRI Scan	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	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 Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters	Immediately after MRI Scan	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 '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.

Countries

Austria, Belgium, Germany, Italy, Spain, United Kingdom, United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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	56
Total	56

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1
Overall Study	MRI Scan not Performed	5
Overall Study	Subject Did not Meet Screening Inclusion/Exclusion Criteria	1
Overall Study	Subject Participation Terminated by Investigator	1

Baseline characteristics

Characteristic	Prodigy MRI or Proclaim Elite MR	—
Age, Continuous	58.4 years STANDARD_DEVIATION 14.4	—
IPG type Proclaim	29 Participants	—
IPG type Prodigy MRI	26 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Austria	1 participants	—
Region of Enrollment Belgium	6 participants	—
Region of Enrollment Germany	7 participants	—
Region of Enrollment Italy	8 participants	—
Region of Enrollment Spain	6 participants	—
Region of Enrollment United Kingdom	5 participants	—
Region of Enrollment United States	23 participants	—
Sex: Female, Male Female	36 Participants	—
Sex: Female, Male Male	19 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 55
other Total, other adverse events	0 / 55
serious Total, serious adverse events	0 / 55

Outcome results

Primary