Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-04 @ 8:44 PM
Study NCT ID:
NCT01556620
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2012-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is NIRS Able to Detect Ischemia Following Brain Insult
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2012-03-15', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PtiO2', 'NIRS'], 'conditions': ['Brain Trauma', 'SAH', 'ICH']}, 'descriptionModule': {'briefSummary': 'We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Brain injury (head trauma, SAH, ICH)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Necessity of monitoring by PtiO2 and ICP\n\nExclusion Criteria:\n\n* Inability to apply NIRS sensor'}, 'identificationModule': {'nctId': 'NCT01556620', 'acronym': 'NIRS', 'briefTitle': 'Is NIRS Able to Detect Ischemia Following Brain Insult', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2', 'orgStudyIdInfo': {'id': 'DCSSA'}}, 'contactsLocationsModule': {'locations': [{'zip': '83000', 'city': 'Toulon', 'country': 'France', 'facility': 'Sainte Anne Military Teaching Hospital', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'overallOfficials': [{'name': 'Henry BORET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Direction Centrale du Service de Santé des Armées'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Médecin en Chef', 'investigatorFullName': 'BORET Henry', 'investigatorAffiliation': 'Direction Centrale du Service de Santé des Armées'}}}}