N/A
N=40
Self Abrading Rapidly Applied Electrode Validation
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Bottom Line
View on ClinicalTrials.gov: NCT02200523 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode — 30; 45 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SARA electrode (Device); Gold cup (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Cleveland Medical Devices Inc
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode |
30; 45 | — |
Summary
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service. The clinical testing in Phase II will investigate patient acceptance, clinician acceptance, time savings, and signal quality for 3 different environments: the large hospital institution, a small rural hospital setting and in an emergency department.
Eligibility Criteria
Inclusion Criteria
- adult and teenage
Exclusion Criteria
- young children
- damaged scalp skin
- sensitive or allergic to electrode paste
Data sourced from ClinicalTrials.gov (NCT02200523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.