MRI Study of Infinity DBS System
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| ClinicalTrials.gov Identifier: NCT03884231 |
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Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : May 17, 2021
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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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 |
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 |
| 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 : | September 30, 2021 |
| Estimated Study Completion Date : | November 30, 2021 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Procedure: MRI imaging procedure
MRI imaging procedure is performed in each subject with Infinity DBS |
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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.
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Procedure: MRI imaging procedure
MRI imaging procedure is performed in each subject with Infinity DBS |
Primary Outcome Measures :
- 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:
- Subject, or a 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.
- Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinican's Manual.
- Subject is willing and able to comply with study requirements.
Exclusion Criteria:
- Subject has another 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 could limit ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the results.
- 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
| Contact: Edward Karst | +1 972 526 4663 | edward.karst@abbott.com | |
| Contact: Nicole Harbert | nicole.harbert@abbott.com |
Locations
| 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 | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Steven Ojemann, MD Steven.Ojemann@ucdenver.edu | |
| Neurosurgery One | Recruiting |
| Littleton, Colorado, United States, 80122 | |
| Contact: David VanSickle, MD vansickledavid@mac.com | |
| United States, Georgia | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Yvan Bamps 404-778-7673 ybamps@emory.edu | |
| Principal Investigator: Robert Gross, MD | |
| 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 | |
| Sweden | |
| Akademiska sjukhuset | Recruiting |
| Uppsala, Uppland, Sweden, 75185 | |
| Contact: Anna Paulsen 46186110000 anna.paulsen@akademiska.se | |
| Principal Investigator: Elena Jiltsova | |
Sponsors and Collaborators
Abbott Medical Devices
| 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: | May 17, 2021 |
| Last Verified: | May 2021 |
| 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 |
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 Synucleinopathies Neurodegenerative Diseases Dyskinesias Neurologic Manifestations |