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OpenTrials
Completed

NCT Number: NCT01573559

ClearView Predicate Comparison Testing

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

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Key information

Conditions

Healthy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EPIC Research & Diagnostics, Inc.

Scottsdale, Arizona, 85255, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation Between ClearView and Predicate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Epic Research & Diagnostics, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2012
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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