Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 4:02 AM
Study NCT ID:
NCT01573559
Status:
COMPLETED
Last Update Posted:
2012-04-09
First Post:
2011-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ClearView Predicate Comparison Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-05', 'studyFirstSubmitDate': '2011-10-03', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between ClearView and Predicate', 'timeFrame': '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.)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ambulatory adults with no apparent health conditions'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.epicdiagnostics.com', 'label': 'EPIC Corporate Website'}]}, 'descriptionModule': {'briefSummary': 'This study serves as a comparison study between the EPIC ClearView and a predicate device.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women ages 18-85.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: Male or Female.\n* Age range: 18 to 85.\n* The subject is able to understand and provide signed consent for the procedure.\n* Every effort will be given to balance subjects by gender, age, and race.\n\nExclusion Criteria:\n\n* Subjects \\< 18 years in age or \\> 85 years in age.\n* Inability or unwillingness to provide informed consent.\n* Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.\n* Subjects missing all or part of any of their fingers.\n* Subjects with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.'}, 'identificationModule': {'nctId': 'NCT01573559', 'briefTitle': 'ClearView Predicate Comparison Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epic Research & Diagnostics, Inc.'}, 'officialTitle': 'ClearView Predicate Comparison Testing', 'orgStudyIdInfo': {'id': 'EPIC-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ClearView/Predicate'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'EPIC Research & Diagnostics, Inc.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Nancy R Rizzo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Epic Research & Diagnostics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epic Research & Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}