Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT05800158
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Butterfly - Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'nasopharyngeal and anterior nasal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1076}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance evaluation of the COVID-19 test', 'timeFrame': 'Between April 2023 and August 2023', 'description': 'Clinical performance evaluation of the COVID-19 test using a composite comparator approach with upper respiratory specimens to meet PPA and NPA requirements.'}, {'measure': 'Identification of adverse events', 'timeFrame': 'Between April 2023 and August 2023', 'description': 'Identify any adverse events or complications associated with the COVID-19 test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COVID-19', 'Coronavirus Infections']}, 'descriptionModule': {'briefSummary': 'This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.', 'detailedDescription': 'The Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (referred to as "COVID-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.\n\nThe purpose of this study is to evaluate the clinical performance of the TaqPath™ COVID-19 Diagnostic PCR Kit (COVID-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of COVID-19 by their health care provider.\n\nA composite comparator approach will be used to evaluate the performance of the COVID-19 test which includes the use of three highly sensitive SARS-CoV-2 molecular assays as comparators. Clinical calls will be compared between COVID-19 test and the three composite comparators. The third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. The Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be composed of participants suspected of COVID-19. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants of all ages must meet the following inclusion criteria to be eligible for participation in the study:\n\n* Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.\n* Individuals with at least one of the following COVID-19 symptoms:\n\n 1. fever or chills\n 2. congestion or runny nose\n 3. headache or fatigue\n 4. muscle or body aches\n\n b. new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea.\n* Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.\n\nExclusion Criteria:\n\nParticipants meeting the following criterion will be excluded from the study:\n\n* Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.\n* Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours'}, 'identificationModule': {'nctId': 'NCT05800158', 'briefTitle': 'Butterfly - Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thermo Fisher Scientific, Inc'}, 'officialTitle': 'Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622', 'orgStudyIdInfo': {'id': 'PCP0131832'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2', 'description': 'Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider.', 'interventionNames': ['Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit']}], 'interventions': [{'name': 'Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit', 'type': 'DIAGNOSTIC_TEST', 'description': 'A reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.', 'armGroupLabels': ['SARS-CoV-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90266', 'city': 'Manhattan Beach', 'state': 'California', 'country': 'United States', 'facility': 'KUR Research at Exer Urgent Care - Manhattan Beach', 'geoPoint': {'lat': 33.88474, 'lon': -118.41091}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'KUR Research at Exer Urgent Care - Redondo Beach', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32055', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Multi Specialty Research Associates', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'D&H National Research Centers', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10465', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'KUR Research at AFC Urgent Care', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '29640', 'city': 'Easley', 'state': 'South Carolina', 'country': 'United States', 'facility': 'KUR Research at AFC Urgent Care', 'geoPoint': {'lat': 34.82984, 'lon': -82.60152}}, {'zip': '29611', 'city': 'Powdersville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'KUR Research at AFC Urgent Care', 'geoPoint': {'lat': 34.79178, 'lon': -82.49291}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ClinSearch', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '75204', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'KUR Research at CityDoc Urgent Care', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thermo Fisher Scientific, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}