Abbott DBS Post-Market Study of Outcomes for Indications over Time
S
S. Elizabeth Zauber
Primary Investigator
Not Recruiting
100 years or below
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
ADROIT (Abbott DBS Post-Market Study of Outcomes for Indications over Time) is an international observational study conducted to gather data on how Abbott DBS systems are being used in the routine clinical practice. It will collect long-term safety and efficacy data for these devices and collect more information about the
different patient populations who are using them.
Detailed description of study
Participants will meet with researchers for an enrollment visit, device implantation, device programming, and follow up visits 6 months after programming. Participants will have yearly follow-up visits for five years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Deep brain stimulation, DBS
-
Age: 100 years or below
-
Gender: All
Inclusion Criteria:
- Scheduled for a new implant or IPG device replacement surgery with a market-release Abbott DBS system within 180 days.
- Participant or a legally acceptable representative must provide written informed consent prior to any study-related procedure.
Exclusion Criteria:
- Participant is currently enrolled or plans to enroll in another investigational study
- Participant has conditions that could limit their ability to participate in the study
- The indication for DBS implant is not Parkinson’s disease or essential tremor
- The lead implant location is not at/close to the STN, GPi, or VIM thalamus
Updated on
01 Aug 2024.
Study ID: 13894, NEUR-ABBOTT-ADROIT
