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NCT04071847Recruiting

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

Abbott Medical Devices

Start Date

11/26/2019

Completion Date

9/1/2030

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.

Detailed 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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days. 2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure. Exclusion Criteria: 1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study. 2. Subject has 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 study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor. 4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Interventions

DEVICE

Deep Brain Stimulation (DBS)

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Conditions

Movement DisordersParkinson DiseaseEssential TremorTremorDystoniaPrimary DystoniaSecondary Dystonia

Locations

University of Aizona Health Sciences

Tucson, Arizona 85274

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California at Davis

Sacramento, California 95817

United States

Colorado Neurodiagnostics

Littleton, Colorado 80120

United States

Neurosurgery One

Littleton, Colorado 80122

United States

University of Miami Hospital

Miami, Florida 33136

United States

University of South Florida - Department of Neurology

Tampa, Florida 33612

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Indiana University

Indianapolis, Indiana 46202

United States

Kansas University Medical Center

Kansas City, Kansas 66160

United States

University of Louisville

Louisville, Kentucky 40202

United States

Willis-Knighton Medical Center

Shreveport, Louisiana 71103

United States

Beth Israe Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Albany Medical Center

Albany, New York 12208

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44106

United States

Ohio State Medical

Columbus, Ohio 43210

United States

Wright State University & Premier Health

Fairborn, Ohio 45324

United States

Center for Interventional Pain & Spine

Exton, Pennsylvania 19341

United States

Thomas Jefferson Department or Neurosurgery

Philadelphia, Pennsylvania 19107

United States

Allegheny General Hospital Department of Neurosurgery

Pittsburgh, Pennsylvania 15212

United States

Texas Movement Disorder Specialist

Georgetown, Texas 78628

United States

University of Utah Hospital

Salt Lake City, Utah 84132

United States

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria 3050

Australia

Helsinki University Central Hospital

Helsinki, Uusimaa 00290

Finland

CHU Gabriel Montpied

Clermont-Ferrand, Auvergne 63003

France

CHU de St Etienne

Saint-Etienne, Auvergne 42270

France

Fondation Rothchild

Paris, ILE

France

CHU Hopital Pasteur

Nice, Provence-Alpes-Azur 6002

France

Universitäts Klinikum Tübingen

Tübingen, Baden-Wurttemberg 72076

Germany

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia 40225

Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia 48149

Germany

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate 55131

Germany

Universitätsklinikum des Saarlandes

Homburg, Saarland 66421

Germany

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, 20246

Germany

Az.Osp. Universitaria di Ferrara

Cona, Emilia-Romagna 44124

Italy

Policlinico Universitario A. Gemelli

Rome, Lazio 00618

Italy

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

Milan, Lombardy 20133

Italy

Hospital Virgen de Rocio

Seville, Andalusia 41013

Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Catalonia 08916

Spain

Hospital Universitario de la Princesa

Madrid, 28006

Spain

Chang Gung Memorial Hospital

Linkou District, Ntaiwan 333

Taiwan

Hualien Tzu Chi Hospital

Hualien City, 97002

Taiwan

The Walton Centre

Liverpool, North West England L9 7LJ

United Kingdom

Southmead Hospita

Bristol, South West England BS10 5NB

United Kingdom

Queen Elizabeth University Hospital

Glasgow, Wdbtshr

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom