ClearView Predicate Comparison Testing

Completed

• Conditions: Healthy

• Registration Number: NCT01573559
• Lead Sponsor: Epic Research & Diagnostics, Inc.

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-10-03
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-05
• Last Update Submitted: 2012-04-05
• Study First Posted: 2012-04-09
• Last Update Posted: 2012-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

EPIC Research & Diagnostics, Inc.; 🇺🇸 Scottsdale, Arizona, United States