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

NCT03884231 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10262
• Study Type: observational
• Target: 74
• Locations: 5 countries
• Sites: 16

Brief Summary

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

Conditions

Movement Disorders; Parkinson Disease; Essential Tremor; Tremor; Dystonia

Keywords

Infinity DBS system; ABT-CIP-1026; Deep Brain Stimulation; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Rate of MRI-related Adverse Events

  Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

  From MRI procedure through 1 month post-MRI procedure

Secondary Outcomes (5)

• Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode

  Immediately after the MRI scan

• Rate of Successful 'Turn on/Off' Functionality for the Stimulation

  Immediately after the MRI scan

• Rate of Successful Adjustments to the Stimulation Amplitude

  Immediately after the MRI scan

• Rate of Successful Interrogation and Download of the IPG Parameters

  Immediately after the MRI scan

• Rate of Successful Ability to Obtain Lead Impedance Measurements

  Immediately after the MRI scan

Study Arms (1)

Infinity DBS System with MR Conditional labelling

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.

Device: Infinity DBS System with MR Conditional labelling

Interventions

Infinity DBS System with MR Conditional labelling DEVICE

Patients implanted with the Infinity DBS system with MR Conditional labeling

Infinity DBS System with MR Conditional labelling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with the Infinity DBS system with MR Conditional labeling.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (16)

Banner University Medical Center Tucson Campus

Tucson, Arizona, 85724, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Neurosurgery One

Littleton, Colorado, 80122, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Willis-Knighton Medical Center

Shreveport, Louisiana, 71103, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Wright State University & Premier Health

Fairborn, Ohio, 45324, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

CHU Gabriel Montpied

Clermont-Ferrand, Auverg N, 63003, France

Location

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, 72076, Germany

Location

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, N. RHIN, 40225, Germany

Location

Universitatsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Universitetsjukhuset I Lund

Lund, Skåne County, 22185, Sweden

Location

Akademiska sjukhuset

Uppsala, Uppland, 75185, Sweden

Location

MeSH Terms

Conditions

Movement Disorders; Parkinson Disease; Essential Tremor; Tremor; Dystonia

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tucker Tomlinson
• Organization: Abbott

tucker.tomlinson@abbott.com

+1/ 972 526 9646

Study Officials

• Binith Cheeran

  Abbott Medical Devices Neuromodulation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: April 10, 2019
• Primary Completion: July 22, 2021
• Study Completion: August 20, 2021
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); FR (1); US (9); DE (3); ES (1)