ClearView Predicate Comparison Testing

Epic Research & Diagnostics

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT01573559

EPIC-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

31 participants in 1 patient group

ClearView/Predicate