A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

Completed

Conditions studied: Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia

In brief

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

Key facts

Study ID

NCT03884231

Run by

Abbott Medical Devices

People needed

74

Starts

2019-04-10

Expected to finish

2021-08-20

Last updated by the study team

2024-11-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
• Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
• Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
• Subject is willing and able to comply with study requirements.

You may not qualify if…

• Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
• Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
• Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
• Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• Subject is currently participating in another clinical investigation that may confound the results of this study.

Where it is running

• Banner University Medical Center Tucson Campus — Tucson, Arizona, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Neurosurgery One — Littleton, Colorado, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Willis-Knighton Medical Center — Shreveport, Louisiana, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Wright State University & Premier Health — Fairborn, Ohio, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Inland Northwest Research — Spokane, Washington, United States
• CHU Gabriel Montpied — Clermont-Ferrand, Auverg N, France
• Universitäts Klinikum Tübingen — Tübingen, Bad-wur, Germany
• Medizinische Einrichtungen der Universität Düsseldorf — Düsseldorf, N. RHIN, Germany
• Universitatsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Rhinela, Germany
• Hospital Universitario de la Princesa — Madrid, Spain
• Universitetsjukhuset I Lund — Lund, Skåne County, Sweden
• Akademiska sjukhuset — Uppsala, Uppland, Sweden

Full record on ClinicalTrials.gov

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