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

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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

Key facts

Study ID

NCT02738840

Run by

Abbott Medical Devices

People needed

56

Starts

2016-10-21

Expected to finish

2020-12-02

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.