Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT06392269
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum obtained from whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood', 'timeFrame': '2 Weeks', 'description': 'To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory.'}], 'secondaryOutcomes': [{'measure': 'Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood', 'timeFrame': '1 Day', 'description': 'To evaluate the performance of Tasso+SST capillary samples collected by lay users in a simulated home environment'}, {'measure': 'Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.', 'timeFrame': '2 Weeks', 'description': 'To demonstrate usability of the Tasso+SST device in naive lay users and in trained HCP populations'}, {'measure': 'Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs', 'timeFrame': '2 weeks', 'description': 'To demonstrate HCP inter-operator precision of Tasso+SST samples'}, {'measure': 'Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user', 'timeFrame': '2 Weeks', 'description': 'To demonstrate lay user intra-operator precision of Tasso+SST samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Serum Analytes']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 - 85 years\n2. Willing and able to provide written informed consent prior to study entry\n3. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol\n4. Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)\n\nExclusion Criteria:\n\n1. Present with abnormal skin integrity or atypical skin health near/on arm collection sites\n2. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee\n3. Laboratory and healthcare personnel.\n4. Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)'}, 'identificationModule': {'nctId': 'NCT06392269', 'briefTitle': 'A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasso Inc.'}, 'officialTitle': 'A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.', 'orgStudyIdInfo': {'id': 'T23-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tasso+', 'description': 'Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture', 'interventionNames': ['Diagnostic Test: Tasso+SST']}], 'interventions': [{'name': 'Tasso+SST', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.', 'armGroupLabels': ['Tasso+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98119', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Massie', 'role': 'CONTACT', 'phone': '206-822-4186'}], 'facility': 'Tasso Research Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Dema Poppa, MS', 'role': 'CONTACT', 'email': 'info@tassoinc.com', 'phone': '(206) 822-4186'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Research results are proprietary; no sharing with other researchers is anticipated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasso Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}