Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-05 @ 3:48 AM
Study NCT ID:
NCT06507566
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Technologies for Point-of-Care Blood Collections by Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-30', 'mcpReleaseN': 4, 'releaseDate': '2025-10-21'}, {'resetDate': '2025-11-18', 'mcpReleaseN': 5, 'releaseDate': '2025-11-05'}, {'resetDate': '2025-12-10', 'mcpReleaseN': 6, 'releaseDate': '2025-11-25'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-10-21'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate the impact of prior training on subsequent Tasso+™ administrations', 'timeFrame': '57', 'description': 'Comparative analyses of sample integrity, reliability, safety, and usability between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57'}], 'primaryOutcomes': [{'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 1', 'description': 'Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis'}, {'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 29', 'description': 'Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis'}, {'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 57', 'description': 'Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis'}, {'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 1', 'description': 'Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting'}, {'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 29', 'description': 'Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting'}, {'measure': 'To assess the sample integrity of Tasso+™', 'timeFrame': 'Day 57', 'description': 'Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting'}, {'measure': 'To assess the testing accuracy of Tasso+™', 'timeFrame': 'Day 1', 'description': 'Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A'}, {'measure': 'To assess the testing accuracy of Tasso+™', 'timeFrame': 'Day 1', 'description': 'Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort B'}, {'measure': 'To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture', 'timeFrame': 'Day 1', 'description': 'Correlation of each chemistry analyte (sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C-reactive protein) between venipuncture and Tasso+™/SST samples for Cohort A'}, {'measure': 'To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture', 'timeFrame': 'Day 1', 'description': 'Correlation of each chemistry analyte (sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C-reactive protein) between venipuncture and Tasso+™/SST samples for Cohort B'}, {'measure': 'To assess the reliability of Tasso+™', 'timeFrame': 'Day 1', 'description': 'Percentage of Tasso+™ device failure'}, {'measure': 'To assess the reliability of Tasso+™', 'timeFrame': 'Day 29', 'description': 'Percentage of Tasso+™ device failure'}, {'measure': 'To assess the reliability of Tasso+™', 'timeFrame': 'Day 57', 'description': 'Percentage of Tasso+™ device failure'}], 'secondaryOutcomes': [{'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 7 days after blood collection on Day 1', 'description': 'Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 7 days after blood collection on Day 29', 'description': 'Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 7 days after blood collection on Day 57', 'description': 'Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 1', 'description': 'Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 29', 'description': 'Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 57', 'description': 'Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 1', 'description': 'Percentage of eligible participants who experience a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 29', 'description': 'Percentage of eligible participants who experience a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Safety)', 'timeFrame': 'Within 28 days after blood collection on Day 57', 'description': 'Percentage of eligible participants who experience a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration'}, {'measure': 'To evaluate Tasso+™ user experience (Tolerability)', 'timeFrame': 'Day 57', 'description': 'Percentage of eligible participants who complete last Tasso+™ administration (Day 57)'}, {'measure': 'To evaluate Tasso+™ user experience (Usability)', 'timeFrame': 'Day 1', 'description': 'Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration'}, {'measure': 'To evaluate Tasso+™ user experience (Usability)', 'timeFrame': 'Day 29', 'description': 'Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration'}, {'measure': 'To evaluate Tasso+™ user experience (Usability)', 'timeFrame': 'Day 57', 'description': 'Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration'}, {'measure': 'To evaluate Tasso+™ user experience (Usability)', 'timeFrame': 'Day 85', 'description': 'Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration'}, {'measure': 'To perform surveillance for SARS-CoV-2 infection', 'timeFrame': 'Day 1', 'description': 'Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1'}, {'measure': 'To perform surveillance for SARS-CoV-2 infection', 'timeFrame': 'Between Days 1 and 57', 'description': 'Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tasso, Tasso+'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A study evaluating technologies for point-of-care use in clinical trials.', 'detailedDescription': 'A study evaluating the Tasso+ blood collection device that enables the safe and convenient collection of blood by a lay person (eg, patient or study participant) under the supervision of an Health Care Provider.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female adults (18 years of age or older, inclusive), at the time of informed consent. Participants who are deemed pregnant by urine pregnancy test at Screening remain eligible.\n* Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.\n* Participant considered healthy or in well-compensated health according to medical history, concomitant medications, and physical examination (including vital signs).\n\nExclusion Criteria:\n\n* Medical history, or physical examination (including vital signs) findings, that suggest to the Investigator that the participant has undiagnosed or untreated medical condition(s) that could confound the AE evaluation and thereby undermine the study objectives.\n* Any known medical history of infection with HIV (CD4\\<200 and/or detectable viral load within the prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive hepatitis C virus antibody).\n* Chronic illness for which a participant's immune system is suspected by the Investigator to be impaired or altered, such as cancer, autoimmune conditions, and diabetes.\n* Participation in another investigational study within 30 days of time of consent or plans to do so during the course of this study.\n* Large tattoos or skin eruptions overlying either of the deltoid muscles that could confound the monitoring for local reactogenicity following Tasso+™ administrations.\n* Use of systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 months; or planned use of medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to screening until end of study.\n* Acute illness within 14 days prior to device use unless it is determined by the Investigator that the illness is mild in severity and unlikely to progress.\n* Of limited legal capacity.\n* Any condition (including suspected alcohol- or drug-related addiction) that precludes adequate understanding, cooperation, and/or compliance with study procedures or any condition that could pose a risk to the participant's safety per Investigator judgment."}, 'identificationModule': {'nctId': 'NCT06507566', 'briefTitle': 'Evaluating Technologies for Point-of-Care Blood Collections by Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alachua Government Services, Inc.'}, 'officialTitle': 'Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings', 'orgStudyIdInfo': {'id': '5309/0024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort A', 'description': 'Samples centrifuged/aliquoted after arrival at central lab.', 'interventionNames': ['Device: Tasso+™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort B', 'description': 'Samples centrifuged/aliquoted at collection Site before shipment to central lab.', 'interventionNames': ['Device: Tasso+™']}], 'interventions': [{'name': 'Tasso+™', 'type': 'DEVICE', 'description': 'The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.', 'armGroupLabels': ['Cohort A', 'Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Victor Salib', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alachua Government Services, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON Government and Public Health Solutions, Inc', 'class': 'UNKNOWN'}, {'name': 'Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}