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

CompletedNot applicableNCT02738840
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Conditions
Interventions
  • Procedure: MRI scan
Sponsor
Abbott Medical Devices
Start date
2016-10-21
Primary completion
2020-12
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Austria, Belgium, Germany, Italy, Spain, United Kingdom, United States
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02738840