CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
SARA electrode +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02200523
NCT02200523N/ACompleted

Self Abrading Rapidly Applied (SARA) Electrode Phase II

Cleveland Medical Devices Inc·interventional·Posted Jul 25, 2014·Updated Aug 13, 2020

In Brief

A clinical study evaluating SARA electrode and Gold cup for ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder). Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 25, 2014
Enrollment StartJun 1, 2014
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago

Interventions

SARA electrodedevice

Gold cupdevice