Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
NCT03794661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2022-03-31
Summary
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
Conditions
Interventions
- DEVICE
-
Clinician programmer electrode screening mode tool
Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Bradley White · Abbott
-
Binith Cheeran · Abbott Medical Devices Neuromodulation
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-26
- Primary Completion
- 2020-12-16
- Completion
- 2020-12-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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