Status:
RECRUITING
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Lead Sponsor:
Abbott Medical Devices
Conditions:
Movement Disorders
Parkinson Disease
Eligibility:
All Genders
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
- Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Exclusion
- Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
- 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.
- Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
- 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.
Key Trial Info
Start Date :
November 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04071847
Start Date
November 26 2019
End Date
September 1 2030
Last Update
January 8 2026
Active Locations (48)
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1
University of Aizona Health Sciences
Tucson, Arizona, United States, 85274
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California at Davis
Sacramento, California, United States, 95817
4
Colorado Neurodiagnostics
Littleton, Colorado, United States, 80120