A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03884231
• Collaborator: (none)
• Enrollment: 71
• Locations: 16
• Actual Duration (Months): 28.4
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
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)

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 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 Design

• Study Type: Observational
• Actual Enrollment: 71 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: Apr 10, 2019
• Actual Primary Completion Date: Jul 22, 2021
• Actual Study Completion Date: Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. MRI-related adverse events [From MRI procedure through 1 month post-MRI procedure.]

   The primary outcome is the rate of MRI-related adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject or subject's 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 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:

1. Subject has another implanted device (active or passive 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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medical Center Tucson Campus	Tucson	Arizona	United States	85724
2	University of Colorado Hospital	Aurora	Colorado	United States	80045
3	Neurosurgery One	Littleton	Colorado	United States	80122
4	Emory University Hospital	Atlanta	Georgia	United States	30322
5	Willis-Knighton Medical Center	Shreveport	Louisiana	United States	71103
6	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
7	Wright State University & Premier Health	Fairborn	Ohio	United States	45324
8	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
9	Inland Northwest Research	Spokane	Washington	United States	99202
10	CHU Gabriel Montpied	Clermont-Ferrand	Auverg N	France	63003
11	Universitäts Klinikum Tübingen	Tübingen	Bad-wur	Germany	72076
12	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	N. Rhin	Germany	40225
13	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz	Rhinela	Germany	55131
14	Hospital Universitario de la Princesa	Madrid		Spain	28006
15	Universitetsjukhuset I Lund	Lund	Skane	Sweden	22185
16	Akademiska sjukhuset	Uppsala	Uppland	Sweden	75185

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Binith Cheeran, Abbott Medical Devices Neuromodulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03884231
• Other Study ID Numbers: ABT-CIP-10262
• First Posted: Mar 21, 2019
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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
• Keywords provided by Abbott Medical Devices: Infinity DBS system; ABT-CIP-1026; Deep Brain Stimulation; Magnetic resonance imaging
• Additional relevant MeSH terms: Parkinson Disease; Dystonia; Tremor; Movement Disorders; Essential Tremor

Study Results

No Results Posted as of Jun 9, 2022