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

Chronic Pain Clinical Trial

— SCS MRI PMCF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738840
• Other study ID #: CRD_800
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: December 2, 2020

Study information

• Verified date: May 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Procedure:
• MRI scan
MRI scan

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post MRI scan
Secondary	Rate of Successful MRI Mode 'Turn on' Functionality	The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.	Immediately before MRI Scan
Secondary	Rate of Successful MRI Mode 'Turn Off' Functionality	The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.	Immediately after MRI Scan
Secondary	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.	Immediately before MRI Scan
Secondary	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.	Immediately after MRI Scan
Secondary	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.	At 1 month follow-up
Secondary	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.	Immediately before MRI Scan
Secondary	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.	Immediately after MRI Scan
Secondary	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.	At 1-month follow-up
Secondary	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.	Immediately before MRI Scan
Secondary	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	Immediately after MRI Scan
Secondary	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	At 1-month follow-up