NCT01573559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

October 3, 2011

Last Update Submit

April 5, 2012

Conditions

Healthy

Keywords

Ambulatory adults with no apparent health conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation Between ClearView and Predicate

    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.

    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.)

Study Arms (1)

ClearView/Predicate

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women ages 18-85.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPIC Research & Diagnostics, Inc.

Scottsdale, Arizona, 85255, United States

Location

Related Links

Study Officials

  • Nancy R Rizzo, PhD

    Epic Research & Diagnostics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

April 9, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

US(1)