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Набира участници NCT04071847

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

Заболявания: Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia Primary Dystonia Secondary Dystonia

Спонсор: Abbott Medical Devices

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане 9
Австралия (1)
Princess Alexandra Hospital
Woolloongabba , Queensland
Финландия (1)
Helsinki University Central Hospital
Helsinki , Uusimaa
Франция (1)
CHU Gabriel Montpied
Clermont-Ferrand , Auvergne
WITHDRAWN
Германия (1)
Universitäts Klinikum Tübingen
Tübingen , Baden-Wurttemberg
Италия (1)
Az.Osp. Universitaria di Ferrara
Cona , Emilia-Romagna
TERMINATED
Испания (1)
Hospital Virgen de Rocio
Seville , Andalusia
Taiwan (1)
Chang Gung Memorial Hospital
Linkou District , Ntaiwan
ACTIVE_NOT_RECRUITING
Великобритания (1)
The Walton Centre
Liverpool , North West England
ACTIVE_NOT_RECRUITING
САЩ (1)
University of Aizona Health Sciences
Tucson , Arizona
ACTIVE_NOT_RECRUITING
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
26.11.2019
Крайна дата
01.09.2030
Регистрационен номер
NCT04071847
Източник
anzctr
Запитване за медицински туризъм

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