Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 7:12 PM
Study NCT ID:
NCT05162495
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2021-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-12-12', 'studyFirstSubmitQcDate': '2021-12-12', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure', 'timeFrame': 'The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample', 'description': 'Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.', 'detailedDescription': "According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.\n\nThe proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.\n\nIndication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.\n\nThe study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral:\n\n1. Male or female subject aged 18 years and above\n2. Subject is able and willing to provide informed consent\n3. Subject is able to complete the breath test.\n\n Arm A:\n4. Requiring a diagnostic or screening RT-PCR test for COVID-19.\n\n Arm B:\n5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.\n\nExclusion Criteria:\n\n1. Male of female subject under the age of 18.\n2. Subject is unable to provide and informed consent, for any reason.'}, 'identificationModule': {'nctId': 'NCT05162495', 'briefTitle': 'Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tera Group'}, 'officialTitle': 'A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.', 'orgStudyIdInfo': {'id': 'TERA-COV-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Requiring a diagnostic or screening RT-PCR test for COVID-19.', 'interventionNames': ['Device: BioStation T101 and TeraTube']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.', 'interventionNames': ['Device: BioStation T101 and TeraTube']}], 'interventions': [{'name': 'BioStation T101 and TeraTube', 'type': 'DEVICE', 'description': 'Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yebgeny Marzon, MD', 'role': 'CONTACT', 'email': 'emarzon@leumit.co.il', 'phone': '+972 50 764 3281'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tera Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}