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ClearView Predicate Comparison Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01573559
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.

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

Condition or disease

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 Type : Observational
Actual Enrollment : 31 participants
Time Perspective: Cross-Sectional
Official Title: ClearView Predicate Comparison Testing
Study Start Date : September 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011


Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women ages 18-85.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01573559

United States, Arizona
EPIC Research & Diagnostics, Inc.
Scottsdale, Arizona, United States, 85255
Sponsors and Collaborators
Epic Research & Diagnostics, Inc.
Principal Investigator: Nancy R Rizzo, PhD Epic Research & Diagnostics, Inc.

Responsible Party: Epic Research & Diagnostics, Inc. Identifier: NCT01573559     History of Changes
Other Study ID Numbers: EPIC-003
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012

Keywords provided by Epic Research & Diagnostics, Inc.:
Ambulatory adults with no apparent health conditions