ClearView Predicate Comparison Testing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01573559

Enrollment

Registered

2012-04-09

Start date

2011-09-30

Completion date

2011-09-30

Last updated

2012-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Ambulatory adults with no apparent health conditions

Brief summary

This study serves as a comparison study between the EPIC ClearView and a predicate device.

Detailed description

The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to be used to determine autonomic response as psychological indicators by measuring the electrical resistance of the skin. The EPIC ClearView is a non-invasive digital bioelectrography instrument that is used to assess the electrophysiology of humans. The measurements are digital photographs taken in a brief exposure to an electric field. These measurements are quantified to produce a standardized Response Scale.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Sex: Male or Female. * Age range: 18 to 85. * The subject is able to understand and provide signed consent for the procedure. * Every effort will be given to balance subjects by gender, age, and race.

Exclusion criteria

* Subjects \< 18 years in age or \> 85 years in age. * Inability or unwillingness to provide informed consent. * Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body. * Subjects missing all or part of any of their fingers. * Subjects with hand tremors or involuntary oscillations (shaking) of the hands that prevent clear imaging.

Design outcomes

Primary

Measure	Time frame	Description
Correlation Between ClearView and Predicate	At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.)	The primary objective of this study is to perform a point-to-point comparison of the EPIC ClearView™ galvanic skin response hand measurements (on a 0-25 scale) to those of a predicate device (on a 0-100 scale). We hypothesize that there will be a statistically significant correlation between the galvanic skin response measurements made by the two devices.

Countries

United States

Outcome results