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

May 26, 2021 updated by: Abbott Medical Devices
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
MRI scan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Rate of the MRI Scan-related Adverse Events
Time Frame: 1 month post MRI scan
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
1 month post MRI scan

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Successful MRI Mode 'Turn on' Functionality
Time Frame: Immediately before MRI Scan
The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.
Immediately before MRI Scan
Rate of Successful MRI Mode 'Turn Off' Functionality
Time Frame: Immediately after MRI Scan
The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.
Immediately after MRI Scan
Rate of Successful 'Turn Off' Functionality for the Stimulation
Time Frame: Immediately before MRI Scan
The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.
Immediately before MRI Scan
Rate of Successful 'Turn on' Functionality for the Stimulation
Time Frame: Immediately after MRI Scan
The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.
Immediately after MRI Scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Time Frame: At 1 month follow-up
The rate of successful 'turn on/off' functionality for the stimulation at 1-month follow-up will be assessed.
At 1 month follow-up
Rate of Successful Adjustments to the Program
Time Frame: 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.
Immediately before MRI Scan
Rate of Successful Adjustments to the Program
Time Frame: Immediately after MRI Scan
The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.
Immediately after MRI Scan
Rate of Successful Adjustments to the Program
Time Frame: 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.
At 1-month follow-up
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
Time Frame: 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.
Immediately before MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Time Frame: 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
Immediately after MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
Time Frame: 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
At 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRD_800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings