Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-31 @ 12:49 AM
Study NCT ID:
NCT05849935
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'through study completion, an average of 2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': "This is a monocentric, 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': 'Adult healthy population', 'healthyVolunteers': True, '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\n 1. Renal disease\n 2. Stoke\n 3. Liver disease\n 4. Pancreatic disease (including diabetes)\n 5. HIV AIDS\n 6. Receiving antibiotic therapy\n 7. Suspected infection\n 8. Immunosuppression\n2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.\n3. Current diagnosis of uncontrolled diabetes.\n4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.\n5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.\n6. Diagnosis and/or treatment of cancer within the last 12 months.\n7. Received immunosuppressive therapy.\n8. Hospitalization for more than 24 hours within the last month.\n9. Reported as currently pregnant or nursing a child\n10. Unable or unwilling to provide the required blood sample for testing.'}, 'identificationModule': {'nctId': 'NCT05849935', 'acronym': 'AB-PSP-007', 'briefTitle': 'abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003', '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-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'abioSCOPE', 'type': 'DIAGNOSTIC_TEST', 'description': 'The abioSCOPE device with the PSP assay is intended to be indicated for ICU admitted patients at risk of developing sepsis. Results of abioSCOPE PSP assay may aid to identify sepsis in critically ill patients, together with all other clinical assessment and laboratory findings.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sundance Clinical', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abionic SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avania', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}