Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-11 @ 2:39 PM
Study NCT ID:
NCT04409561
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of reference range interval of PSP', 'timeFrame': 'Day 1', 'description': 'To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.'}], 'secondaryOutcomes': [{'measure': 'Collect medical data of healthy volunteer', 'timeFrame': 'Day 1', 'description': 'To collect medical data from the 150 study participants using a volunteer questionnaire'}, {'measure': 'Obtain well characterised samples library to be used for future tests development', 'timeFrame': 'Day 1', 'description': 'Whole blood collection from 150 healthy subject to be used for future tests development.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sepsis', 'Pancreatic Stone Protein', 'Immunoassay', 'Abionic', 'Healthy population', 'Point-of-care device'], 'conditions': ['Sepsis', 'Septic Shock', 'Healthy']}, 'descriptionModule': {'briefSummary': "This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '150 generally healthy adults. This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged ≥ 18 years.\n2. Apparently healthy as determined by a subject questionnaire.\n\nExclusion Criteria:\n\n1\\) Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:\n\n1. Heart disease\n2. Stroke\n3. Renal disease\n4. Liver disease\n5. Pancreatic disease\n6. Chronic obstructive pulmonary disorder\n7. Bleeding disorders\n8. Hypercalcitoninemia\n9. HIV AIDS\n10. Receiving antibiotic therapy\n11. Suspected infection\n12. Immunosuppression\n\n 2\\) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.\n\n 3\\) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.\n\n 4\\) Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.\n\n 5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care.\n\n 6\\) Current diagnosis of cancer within the last 12 months.\n\n 7\\) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.\n\n 8\\) Hospitalization for more than 24 hours within the last 3 months.\n\n 9\\) Reported as currently pregnant or nursing a child\n\n 10\\) Unable or unwilling to provide the required blood sample for testing.\n\n 11\\) Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.'}, 'identificationModule': {'nctId': 'NCT04409561', 'briefTitle': 'Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abionic SA'}, 'officialTitle': 'A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population', 'orgStudyIdInfo': {'id': 'AB-PSP-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interventions', 'description': 'This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.', 'interventionNames': ['Device: Blood collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'DEVICE', 'description': '9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits', 'armGroupLabels': ['Interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Health St. Vincent', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abionic SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boston Biomedical Associates', 'class': 'OTHER'}, {'name': 'Ocean State Clinical Coordinating Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}