ClearView Predicate Comparison Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01573559
First received: October 3, 2011
Last updated: April 5, 2012
Last verified: April 2012

October 3, 2011
April 5, 2012
September 2011
September 2011   (final data collection date for primary outcome measure)
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.) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01573559 on ClinicalTrials.gov Archive Site
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ClearView Predicate Comparison Testing
ClearView Predicate Comparison Testing

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

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Men and women ages 18-85.

Healthy
Not Provided
ClearView/Predicate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01573559
EPIC-003
No
Epic Research & Diagnostics, Inc.
Epic Research & Diagnostics, Inc.
Not Provided
Principal Investigator: Nancy R Rizzo, PhD Epic Research & Diagnostics, Inc.
Epic Research & Diagnostics, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP