Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Last updated: May 24, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Essential Tremor

Tardive Dyskinesia

Neurologic Disorders

Treatment

Deep Brain Stimulation (DBS)

Clinical Study ID

NCT04071847
ABT-CIP-10300
  • All Genders

Study Summary

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is scheduled for a new implant or IPG device replacement surgery with amarket-released Abbott DBS system within 180 days.

  2. Subject, or a legally acceptable representative, must provide written informedconsent prior to any study-related procedure.

Exclusion

Exclusion Criteria:

  1. Subject is currently enrolled or plans to enroll in an investigational study thatmay confound the results of this study.

  2. Subject has anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the study or to comply with follow-uprequirements, or impact the scientific soundness of the study results.

  3. Study center is located in the United States, and indication for DBS implant is notParkinson's disease or disabling tremor.

  4. Study center is located in the United States, and the intended lead implant locationis not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation (DBS)
Phase:
Study Start date:
November 26, 2019
Estimated Completion Date:
September 30, 2030

Study Description

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.

Subjects will be followed for 5 years after the initial programming visit.

Connect with a study center

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital - City Campus

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Helsinki University Central Hospital

    Helsinki, Uusimaa 00290
    Finland

    Active - Recruiting

  • CHU Gabriel Montpied

    Clermont Ferrand, Auvergne 63003
    France

    Site Not Available

  • CHU de St Etienne

    Saint-Étienne, Auvergne 42270
    France

    Active - Recruiting

  • Fondation Rothchild

    Paris, ILE
    France

    Site Not Available

  • CHU Hopital Pasteur

    Nice, Provence-Alpes-Azur 6002
    France

    Active - Recruiting

  • Universitäts Klinikum Tübingen

    Tübingen, Baden-Wurttemberg 72076
    Germany

    Active - Recruiting

  • Medizinische Einrichtungen der Universität Düsseldorf

    Düsseldorf, North Rhine-Westphalia 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia 48149
    Germany

    Active - Recruiting

  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate 55131
    Germany

    Active - Recruiting

  • UKE Hamburg (Universitatsklinik Eppendorf)

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Az.Osp. Universitaria di Ferrara

    Cona, Emilia-Romagna 44124
    Italy

    Terminated

  • Policlinico Universitario A. Gemelli

    Roma, Latium 00618
    Italy

    Active - Recruiting

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milano, Lombardy 20133
    Italy

    Active - Recruiting

  • Hospital Virgen de Rocio

    Sevilla, Andalusia 41013
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Catalonia 08916
    Spain

    Active - Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Chang Gung Memorial Hospital

    LinKou, Ntaiwan 333
    Taiwan

    Active - Recruiting

  • Hualien Tzu Chi Hospital

    Hualien City, 97002
    Taiwan

    Active - Recruiting

  • The Walton Centre

    Liverpool, North West England L9 7LJ
    United Kingdom

    Active - Recruiting

  • Southmead Hospita

    Bristol, South West England BS10 5NB
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Wdbtshr
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • University of Aizona Health Sciences

    Tucson, Arizona 85274
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California at Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Colorado Neurodiagnostics

    Littleton, Colorado 80120
    United States

    Terminated

  • Neurosurgery One

    Littleton, Colorado 80122
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of South Florida - Department of Neurology

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Willis-Knighton Medical Center

    Shreveport, Louisiana 71103
    United States

    Terminated

  • Beth Israe Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Ohio State Medical

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Wright State University & Premier Health

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Center for Interventional Pain & Spine

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Thomas Jefferson Department or Neurosurgery

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Allegheny General Hospital Department of Neurosurgery

    Pittsburgh, Pennsylvania 15212
    United States

    Terminated

  • Michael Disorder Soileau

    Georgetown, Texas 78628
    United States

    Active - Recruiting

  • Texas Movement Disorder Specialist

    Georgetown, Texas 78628
    United States

    Active - Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

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