Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-30 @ 5:25 AM
Study NCT ID:
NCT04343495
Status:
WITHDRAWN
Last Update Posted:
2022-09-29
First Post:
2020-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UV and Bluelight Dosimetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left institution and study has not begun enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings.', 'timeFrame': 'Time Frame: 1 year', 'description': 'After sensors are removed researchers will collect dosimetry data using a phone application using Near Field Communication (NFC) with a phone that is restricted to research use only in this study. Location, indoor/outdoor conditions and time that the devices are used will be recorded by the study team.\n\nLocation, external environmental factors (weather, UV index) and activities will be recorded by the research administrators.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Environmental Exposure']}, 'descriptionModule': {'briefSummary': 'The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Subjects willing and able to comply with requirements of the protocol\n* Subjects speaking English\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Subjects unwilling and unable to comply with requirements of the protocol\n* History of skin allergy to medical adhesive tape or rubber bands/elastic\n* Lack of proficiency in English\n* Skin disorders affecting skin integrity'}, 'identificationModule': {'nctId': 'NCT04343495', 'briefTitle': 'UV and Bluelight Dosimetry', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Pilot Studies of UV-A, UV-B, and Blue-light Dosimetry Sensors', 'orgStudyIdInfo': {'id': 'STU00209872'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wearable Ultra Violet (UV) and blue-light sensors', 'type': 'DEVICE', 'description': 'Non-blinded'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shuai (Steve) Xu', 'investigatorAffiliation': 'Northwestern University'}}}}