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A Post-Market Study Evaluating the MR Conditional Neuromodulation Systems (Prodigy MRI)

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ClinicalTrials.gov Identifier: NCT02738840
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
A post market study evaluating the St Jude medical MR conditional neurostimulation systems.

Condition or disease Intervention/treatment
Chronic Pain Procedure: MRI scan

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 'Technischer Uberwachungs-Verein (TUV)

Study Type : Observational
Estimated Enrollment : 49 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Post-Market Study Evaluating the MR Conditional Neuromodulation Systems
Study Start Date : October 2016
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: MRI scan
    MRI scan


Primary Outcome Measures :
  1. the rate of the MRI scan-related adverse events [ Time Frame: 1 month post MRI scan ]
    The primary objective of the study is to confirm the safety of the SJM MR conditional neurostimulation system when performing a MRI scan


Secondary Outcome Measures :
  1. the rate of successful device functionality checks [ Time Frame: 1 month post MRI scan ]
    The secondary objective is to confirm that the MRI scan does not affect the SJM MR conditional neurostimulation systems functionality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population enrolled in this study will be comprised of male and female subjects. Subjects have to meet specific eligibility criteria in order to participate in the study. 49 subjects will be enrolled. Data from only 1 scan per subject will be collected in the study.
Criteria

Inclusion Criteria:

  • Subject has been implanted with a commercially available SJM MR conditional neurostimulation system.
  • Subject is scheduled to receive a MRI scan in compliance with the SJM IFU for the MR conditional neurostimulation system.
  • Subject is at least 18 years of age
  • Subject must be willing and able to comply with study requirements
  • Subject must indicate his/her understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

  • Subject has another implanted device (active or passive implanted device) that prohibits safe scanning
  • Subject has previously experienced a MRI scan related adverse event

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738840


Contacts
Contact: Nicole Harbert nicole.harbert@abbott.com
Contact: Monique Van Bree mvanbree@sjm.com

Locations
Austria
Wilhelminenspital Recruiting
Wien, Austria, 1160
Contact: Burkhard Gustorff, DEAA    +43149150 ext 4001      
Contact: Herwig Kloimstein, MD    +43149150 ext 4008      
Belgium
St Augustinus Ziekenhuis Active, not recruiting
Wilrijk, Belgium
Germany
Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf Recruiting
Dusseldorf, Germany
Contact: Jan Vesper, MD       jan.vesper@med.uni-duesseldorf.de   
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera Recruiting
Gera, Germany
Contact: Michael Kretzschmar, MD       Michael.Kretzschmar@wkg.srh.de   
Italy
Policlinico S.S. Annunziata Active, not recruiting
Chieti, Italy
l'Azienda Ospedaliero- Universitaria Pisa Recruiting
Pisa, Italy, 56126
Contact: Giuliano Carolis, MD       giulianodecarolis@gmail.com   
Ospedale Civile Santa Maria Delle Croci Active, not recruiting
Ravenna, Italy
Spain
Hospital Virgen de Rocio Active, not recruiting
Sevilla, Spain
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Nicole Harbert Abbott

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02738840     History of Changes
Other Study ID Numbers: CRD_800
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms