NCT02200523

Self Abrading Rapidly Applied Electrode Validation

Self Abrading Rapidly Applied (SARA) Electrode Phase II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cleveland Medical Devices Inc · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. This proposed single-use electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the backing, the technician simply parts the hair with one hand and with the other hand rubs the electrode back and forth and then presses the electrode into position on the scalp. The proposed system combines the cumbersome and time-consuming skin preparation, electrode preparation and electrode fixation into one easy step. 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.

Conditions

• ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Interventions

Type	Name	Description
DEVICE	SARA electrode
DEVICE	Gold cup

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2014-07-25
• Last updated: 2020-08-13
• Results posted: 2020-08-13

Locations

1 site across 1 country: United States