A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
NCT ID: NCT03884231
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
74 participants
OBSERVATIONAL
2019-04-10
2021-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Infinity DBS System with MR Conditional labelling
The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain.
Infinity DBS System with MR Conditional labelling
Patients implanted with the Infinity DBS system with MR Conditional labeling
Interventions
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Infinity DBS System with MR Conditional labelling
Patients implanted with the Infinity DBS system with MR Conditional labeling
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Subject is willing and able to comply with study requirements.
Exclusion Criteria
2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
4. 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.
5. Subject is currently participating in another clinical investigation that may confound the results of this study.
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Binith Cheeran
Role: STUDY_DIRECTOR
Abbott Medical Devices Neuromodulation
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10262
Identifier Type: -
Identifier Source: org_study_id
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