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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).
Full description
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
Enrollment
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Parkinson's disease patients:
Essential tremor patients:
EXCLUSION CRITERIA
Primary purpose
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Interventional model
Masking
8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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