Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 10:22 PM
Study NCT ID:
NCT02809651
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2016-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2016-06-18', 'studyFirstSubmitQcDate': '2016-06-18', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infrascanner', 'Intracranial hemorrhage'], 'conditions': ['Ischemic Stroke', 'Brain Tumor', 'Brain Surgery', 'Intracranial Hemorrhage', 'Headache', 'Head Trauma']}, 'descriptionModule': {'briefSummary': 'The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.', 'detailedDescription': 'Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).\n\nTherefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ischemic stroke diagnosed by clinical examination and CT-scan\n* Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI\n* Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan\n* Patients that have undergone brain surgery\n* Patients with a normal CT-scan of the brain after head trauma\n* Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02809651', 'briefTitle': 'Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner', 'orgStudyIdInfo': {'id': '16/015U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ischemic stroke', 'description': 'patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan', 'interventionNames': ['Device: Infrascanner']}, {'type': 'EXPERIMENTAL', 'label': 'Brain tumor', 'description': 'patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI', 'interventionNames': ['Device: Infrascanner']}, {'type': 'EXPERIMENTAL', 'label': 'Brain surgery', 'description': 'patients that have undergone brain surgery', 'interventionNames': ['Device: Infrascanner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intracranial hemorrhage', 'description': 'patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan', 'interventionNames': ['Device: Infrascanner']}, {'type': 'EXPERIMENTAL', 'label': 'Headache', 'description': 'patients with headache complaints and a normal CT-scan of the brain', 'interventionNames': ['Device: Infrascanner']}, {'type': 'EXPERIMENTAL', 'label': 'Headtrauma', 'description': 'patients with head trauma and a normal CT-scan of the brain', 'interventionNames': ['Device: Infrascanner']}], 'interventions': [{'name': 'Infrascanner', 'type': 'DEVICE', 'description': 'bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.', 'armGroupLabels': ['Brain surgery', 'Brain tumor', 'Headache', 'Headtrauma', 'Intracranial hemorrhage', 'Ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Pascal Vanelderen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'member of Staff'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Pascal Vanelderen', 'investigatorAffiliation': 'Ziekenhuis Oost-Limburg'}}}}