A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03884231|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : June 9, 2022
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|Condition or disease||Intervention/treatment|
|Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia||Device: Infinity DBS System with MR Conditional labelling (Leads-only configuration) Device: Infinity DBS System with MR Conditional labelling (Full system configuration)|
This study will be conducted as an international, multicenter,observational, prospective, single-arm, post-market clinical follow-up (PMCF). The study will evaluate the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure is performed according to the approved guidance.
The study will enroll approximately 74 subjects at up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling is approved, including the European Union and the United States. Subjects who have a leads-only configuration or a full system configuration will participate in the study. Subjects may be enrolled when an MRI procedure is prescribed per standard of care.
Each subject will be limited to one MRI procedure during the course of the study. Data collected include MRI parameters and any adverse events that occur during or after the procedure. There will be an office visit to document any adverse events and verify device functionality for all subjects one month (30 days ± 14 days) post-MRI follow-up visit after the initial MRI procedure is performed.
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|Official Title:||A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling|
|Actual Study Start Date :||April 10, 2019|
|Actual Primary Completion Date :||July 22, 2021|
|Actual Study Completion Date :||August 20, 2021|
Infinity DBS System with MR Conditional labelling (Leads-only configuration)
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. The leads-only configuration consists of at least one implanted lead protected with a lead protection boot, as well as an optional cranial burr hole cover. Any leads must be completely implanted with the surgical incision closed.
Device: Infinity DBS System with MR Conditional labelling (Leads-only configuration)
Patients will undergo MRI procedures using Leads-only configuration
Infinity DBS System with MR Conditional labelling (Full system configuration)
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. The full system configuration consists of at least one IPG, one lead, one extension, and an optional cranial burr hole cover. All devices must be completely implanted with the surgical incision closed.
Device: Infinity DBS System with MR Conditional labelling (Full system configuration)
Patients will undergo MRI procedures using Full system configuration
- MRI-related adverse events [ Time Frame: From MRI procedure through 1 month post-MRI procedure. ]The primary outcome is the rate of MRI-related adverse events.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884231
|United States, Arizona|
|Banner University Medical Center Tucson Campus|
|Tucson, Arizona, United States, 85724|
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Littleton, Colorado, United States, 80122|
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|United States, Louisiana|
|Willis-Knighton Medical Center|
|Shreveport, Louisiana, United States, 71103|
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08901|
|United States, Ohio|
|Wright State University & Premier Health|
|Fairborn, Ohio, United States, 45324|
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|United States, Washington|
|Inland Northwest Research|
|Spokane, Washington, United States, 99202|
|CHU Gabriel Montpied|
|Clermont-Ferrand, Auverg N, France, 63003|
|Universitäts Klinikum Tübingen|
|Tübingen, Bad-wur, Germany, 72076|
|Medizinische Einrichtungen der Universität Düsseldorf|
|Düsseldorf, N. Rhin, Germany, 40225|
|UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz|
|Mainz, Rhinela, Germany, 55131|
|Hospital Universitario de la Princesa|
|Madrid, Spain, 28006|
|Universitetsjukhuset I Lund|
|Lund, Skane, Sweden, 22185|
|Uppsala, Uppland, Sweden, 75185|
|Study Director:||Binith Cheeran||Abbott Medical Devices Neuromodulation|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|First Posted:||March 21, 2019 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
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