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Trial record 1 of 1 for:    infinity mri
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MRI Study of Infinity DBS System

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ClinicalTrials.gov Identifier: NCT03884231
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date March 19, 2019
First Posted Date March 21, 2019
Last Update Posted Date May 17, 2021
Actual Study Start Date April 10, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI Study of Infinity DBS System
Official Title A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Movement Disorders
  • Parkinson Disease
  • Essential Tremor
  • Tremor
  • Dystonia
Intervention Procedure: MRI imaging procedure
MRI imaging procedure is performed in each subject with Infinity DBS
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: MRI imaging procedure
  • 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.
    Intervention: Procedure: MRI imaging procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 19, 2019)
74
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Edward Karst +1 972 526 4663 edward.karst@abbott.com
Contact: Nicole Harbert nicole.harbert@abbott.com
Listed Location Countries Germany,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884231
Other Study ID Numbers ABT-CIP-10262
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date May 2021