Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 1:05 PM
Study NCT ID:
NCT05198869
Status:
UNKNOWN
Last Update Posted:
2022-01-20
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpotLight-19 Research & Development Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'spectra indicative of COVID-19 infection', 'timeFrame': 'immediate upon scan', 'description': 'specific wavelengths of light that correlate with COVID-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Screening']}, 'descriptionModule': {'briefSummary': 'In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.', 'detailedDescription': "Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19.\n\nAll individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Qualifies for COVID-19 testing as per Assessment Site protocol; or\n* Is capable of cooperating with testing\n* Is clinically stable such that the testing protocol may be completed safely\n\nExclusion Criteria:\n\n* Extreme fingertip scarring or other physical condition that prevents use of the device'}, 'identificationModule': {'nctId': 'NCT05198869', 'briefTitle': 'SpotLight-19 Research & Development Study', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'SpotLight-19 Research and Development Study', 'orgStudyIdInfo': {'id': '20210902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Spectral scan (All participants)', 'description': '1. Fitzpatrick skin assessment.\n2. Fingertip scanned using the SpotLight-19 device. The scan is approximately 10-20 seconds. Participants will not feel any sensation from the device, i.e., no heat, no pain, no cold, no vibration or pressure.\n3. Information collected from the medical record regarding participant age, COVID-19 vaccination status, presence of COVID-19 symptoms, and PCR test result.', 'interventionNames': ['Device: Spectral scan']}], 'interventions': [{'name': 'Spectral scan', 'type': 'DEVICE', 'description': 'Consenting participants will have a SpotLight-19 scan', 'armGroupLabels': ['Spectral scan (All participants)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1S 5T1', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nadine Drosdowech', 'role': 'CONTACT'}, {'name': 'Ken Farion, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'COVID-19 CHEO Assessment Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1S5T1', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Cassie Matthews', 'role': 'CONTACT'}, {'name': 'Alan Forster, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'COVID-19 Assessment Centre for Adults', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Alison Jennings', 'role': 'CONTACT', 'email': 'ajennings@ohri.ca', 'phone': '6137985555', 'phoneExt': '19717'}, {'name': 'Austin MacIntyre', 'role': 'CONTACT', 'email': 'amacintyre@isbrgcorp.com'}], 'overallOfficials': [{'name': 'Rae Lake, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ISBRG Corp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'ISBRG Corp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alan Forster', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}