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
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: ClearView Predicate Comparison Testing

Further study details as provided by Epic Research & Diagnostics, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ClearView/Predicate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men and women ages 18-85.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573559

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

Additional Information:
No publications provided

Responsible Party: Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01573559     History of Changes
Other Study ID Numbers: EPIC-003
Study First Received: October 3, 2011
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014