Seizure Advisory System Feasibility Study
NCT01043406 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2012-10-24
Summary
The purpose of this prospective, single-arm, unblinded, multicenter clinical study is to evaluate the safety and effectiveness of the NeuroVista Seizure Advisory System (SAS) in patients with medically refractory epilepsy. A total of 15 subjects will be implanted at up to three study sites.
Conditions
Interventions
- DEVICE
-
Seizure Advisory System
Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.
Sponsors & Collaborators
-
NeuroVista Corporation
lead INDUSTRY
Principal Investigators
-
Warren D Sheffield, VMD, PhD · NeuroVista Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-31
- Primary Completion
- 2012-08-31
- Completion
- 2012-10-31
Countries
- Australia
Study Locations
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