NCT02200523

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

February 5, 2014

Results QC Date

July 22, 2019

Last Update Submit

August 11, 2020

Conditions

ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Keywords

EEGelectrode

Outcome Measures

Primary Outcomes (1)

  • Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode

    The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.

    up to 1 hour

Study Arms (2)

SARA electrode

EXPERIMENTAL

new electrode

Device: SARA electrode

Gold cup

ACTIVE COMPARATOR

gold standard

Device: Gold cup

Interventions

SARA electrodeDEVICE
SARA electrode
Gold cupDEVICE
Gold cup

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult and teenage

You may not qualify if:

  • young children
  • damaged scalp skin
  • sensitive or allergic to electrode paste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Research Institute

Cleveland, Ohio, 44109, United States

Location

Results Point of Contact

Title
Sarah Weimer
Organization
Cleveland Medical Devices
sweimer@clevemed.com
216-791-6720

Study Officials

  • Sarah Weimer

    Great Lakes NeuroTechnologies Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

July 25, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

August 13, 2020

Results First Posted

August 13, 2020

Record last verified: 2020-08

Locations

US(1)