Clinical trial NCT02738840: A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Official title: A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: International, multicenter, prospective, and single-arm design
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: The Rate of the MRI Scan-related Adverse Events
timeFrame: 1 month post MRI scan
Secondary outcomes:
measure: Rate of Successful MRI Mode 'Turn on' Functionality
timeFrame: Immediately before MRI Scan
measure: Rate of Successful MRI Mode 'Turn Off' Functionality
timeFrame: Immediately after MRI Scan
measure: Rate of Successful 'Turn Off' Functionality for the Stimulation
timeFrame: Immediately before MRI Scan
measure: Rate of Successful 'Turn on' Functionality for the Stimulation
timeFrame: Immediately after MRI Scan
measure: Rate of Successful 'Turn on/Off' Functionality for the Stimulation
timeFrame: At 1 month follow-up
measure: Rate of Successful Adjustments to the Program
timeFrame: Immediately before MRI Scan
measure: Rate of Successful Adjustments to the Program
timeFrame: Immediately after MRI Scan
measure: Rate of Successful Adjustments to the Program
timeFrame: At 1-month follow-up
measure: Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters
timeFrame: Immediately before MRI Scan
measure: Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
timeFrame: Immediately after MRI Scan
measure: Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters
timeFrame: At 1-month follow-up
Other outcomes:
Locations:
city: Napa
country: United States
facility: Napa Valley Orthopedic Medical Group
state: California
city: Rochester
country: United States
facility: Unity Spine Center
state: New York
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Vienna
country: Austria
facility: Wilhelminenspital Wien
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus
city: Dusseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
city: Gera
country: Germany
facility: Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
state: Ykshre
Study officials:
affiliation: Abbott
name: Nicole Harbert
role: STUDY_DIRECTOR
References: