Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 12:16 AM
Study NCT ID:
NCT03246503
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BiliCam Clinical Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uncjat@google.com', 'phone': '2064194923', 'title': 'James Taylor', 'organization': 'BiliCam, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events related to the study device through study completion, for an average of 30 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BCB - TSB Correlation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'paramType': 'Pearson correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.77', 'ciUpperLimit': '.87', 'pValueComment': 'statistical significance of Pearson correlation coefficient', 'estimateComment': 'Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.', 'groupDescription': 'Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.', 'statisticalMethod': 'Pearson correlation coefficient', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'Pearson correlation coefficient between paired BCB- TSB measurements', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device.'}, {'type': 'SECONDARY', 'title': 'Intercept of Regression Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.13', 'groupId': 'OG000', 'lowerLimit': '3.35', 'upperLimit': '4.91'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'paramType': 'intercept of regression line', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.13', 'ciLowerLimit': '3.35', 'ciUpperLimit': '4.91', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 't-statistic from regression analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid paired BCB and TSB values'}, {'type': 'SECONDARY', 'title': 'Slope of Regression Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '0.76'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.76', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 't-statistic from regression analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).', 'unitOfMeasure': 'slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid paired BCB and TSB values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Received phtototherapy prior to study visit=4, blood specimen not obtained =1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.\n\nBiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'spread': '27.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A total of 203 participants were consented. Age was not obtained until the study visit; 150 participants had a study visit'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Age was only measured on the 150 participants who completed a study visit'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-01', 'size': 287562, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-17T20:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2019-07-08', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2017-08-08', 'dispFirstSubmitQcDate': '2022-06-08', 'resultsFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2017-08-08', 'dispFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-08', 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCB - TSB Correlation', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'Pearson correlation coefficient between paired BCB- TSB measurements'}], 'secondaryOutcomes': [{'measure': 'Intercept of Regression Line', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).'}, {'measure': 'Slope of Regression Line', 'timeFrame': 'Newborns up to 192 hours old', 'description': 'The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'conditions': ['Newborn Jaundice']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.', 'detailedDescription': "Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.\n\nFor the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '191 Hours', 'minimumAge': '0 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn born at ≥ 35 weeks gestation\n* Parent speaks and reads English\n* Parent provides written informed consent\n\nExclusion Criteria:\n\n* previous or ongoing treatment with phototherapy for hyperbilirubinemia\n* Medical or other complications that preclude completion of the study'}, 'identificationModule': {'nctId': 'NCT03246503', 'briefTitle': 'BiliCam Clinical Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'BiliCam, LLC'}, 'officialTitle': 'BiliCam Clinical Validation Study', 'orgStudyIdInfo': {'id': '52488'}, 'secondaryIdInfos': [{'id': 'R44HD090778', 'link': 'https://reporter.nih.gov/quickSearch/R44HD090778', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Newborns', 'description': 'Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \\< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.', 'interventionNames': ['Device: BiliCam estimated bilirubin (BCB)']}], 'interventions': [{'name': 'BiliCam estimated bilirubin (BCB)', 'type': 'DEVICE', 'description': 'Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care', 'armGroupLabels': ['Newborns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19017', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hopsital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BiliCam, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}