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MRI Study of Infinity DBS System

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884231
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This is a study of subjects with the St. Jude Medical Infinity deep brain stimulation (DBS) system who undergo an MRI imaging procedure. Enrollment may occur before DBS implant, or when an MRI scan is planned in a subject with an existing implant. There will be a follow-up visit one month after the MRI procedure to document any adverse events and verify device functionality.

Condition or disease Intervention/treatment
Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia Procedure: MRI imaging procedure

Detailed Description:

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 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 used to confirm DBS electrode placement or prescribed for diagnostic purposes.

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) after the MRI procedure is performed.

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021


Group/Cohort Intervention/treatment
Leads-only configuration
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.
Procedure: MRI imaging procedure
MRI imaging procedure is performed in each subject with Infinity DBS

Full system configuration
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.
Procedure: MRI imaging procedure
MRI imaging procedure is performed in each subject with Infinity DBS




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, dystonia, or disabling tremor implanted with the Infinity DBS system with MR Conditional labeling. Subjects may be enrolled prior to implant, or may already have the DBS system implanted.
Criteria

Inclusion Criteria:

  1. Subject, or a legally acceptable representative, must provide written informed consent prior to any clinical investigation related procedure.
  2. Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling.
  3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinican's Manual.
  4. Subject is willing and able to comply with study requirements.

Exclusion Criteria:

  1. Subject has another implanted device that prohibits safe scanning.
  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 could limit ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the results.
  5. Subject is participating in another clinical investigation that may confound the results of this study.

Information from the National Library of Medicine

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


Contacts
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Contact: Edward Karst +1 972 526 4663 edward.karst@abbott.com
Contact: Nicole Harbert nicole.harbert@abbott.com

Locations
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United States, Arizona
Banner University Medical Center Tucson Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Willard Kasoff, MD         
Contact       wkasoff@surgery.arizona.edu   
United States, Colorado
University of Colorado Hospital Active, not recruiting
Aurora, Colorado, United States, 80045
Neurosurgery One Recruiting
Littleton, Colorado, United States, 80122
Contact: David VanSickle, MD       vansickledavid@mac.com   
United States, Louisiana
Willis-Knighton Medical Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Jessica Wilden, MD       wildenmd@gmail.com   
United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Eric Hargreaves, MD       hargreer@rwjms.rutgers.edu   
United States, Ohio
Wright State University & Premier Health Recruiting
Dayton, Ohio, United States, 45409
Contact: Daniel Gaudin, MD       dgaudin@premierhealth.com   
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Ramsey Falconer, MD       Drew.Falconer@inova.org   
United States, Washington
Inland Northwest Research Completed
Seattle, Washington, United States, 99202
Germany
Universitäts Klinikum Tübingen Recruiting
Tübingen, Baden-Wurttemberg, Germany, 72076
Contact: Alireza Gharabaghi, MD       alireza.gharabaghi@uni-tuebingen.de   
Medizinische Einrichtungen der Universität Düsseldorf Recruiting
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Contact: Philipp Joerg Slotty, MD       Slotty@med.uni-duesseldorf.de   
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Sergiu Groppa, MD       sergiu.groppa@unimedizin-mainz.de   
Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Cristina Torres Diaz, MD       cristinatorresdiaz@yahoo.es   
Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03884231    
Other Study ID Numbers: ABT-CIP-10262
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Tremor
Essential Tremor
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations