Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-02 @ 6:42 PM
Study NCT ID:
NCT02977520
Status:
UNKNOWN
Last Update Posted:
2016-11-30
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D066330', 'term': 'Printing, Three-Dimensional'}], 'ancestors': [{'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of operation', 'timeFrame': '1 to 3 hours'}]}, 'conditionsModule': {'conditions': ['Printing, Three-Dimensional, Simulation Training']}, 'descriptionModule': {'briefSummary': "Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years-80 years;\n* Hunt-Hess grade: 0-4;\n* Without other stroke, brain trauma and other neurological disease;\n* Without cerebral hernia;\n* Cystic aneurysm.\n\nExclusion Criteria:\n\n* Age: less than 18 years or above 80 years;\n* Hunt-Hess grade is 5;\n* With serious previous disorder of multiple organ;\n* Acute cerebral hernia;\n* Aneurysms were fusiform or serpentine expansion.'}, 'identificationModule': {'nctId': 'NCT02977520', 'acronym': 'PAOCA', 'briefTitle': 'Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Luhe Hospital'}, 'officialTitle': 'Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms', 'orgStudyIdInfo': {'id': 'TWKY-2016-ZD-01-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': "Obtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.", 'interventionNames': ['Procedure: Printing, Three-Dimensional']}, {'type': 'NO_INTERVENTION', 'label': 'general group', 'description': 'Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.'}], 'interventions': [{'name': 'Printing, Three-Dimensional', 'type': 'PROCEDURE', 'description': 'To establish 3D model of cerebral aneurysms and have preoperative evaluation.', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101149', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'QING HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangqing@ccmu.edu.cn', 'phone': '86-10-69543901', 'phoneExt': '2053'}, {'name': 'QING HUANG, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Luhe hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'QING HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangqing@ccmu.edu.cn', 'phone': '86-10-69543901', 'phoneExt': '2053'}, {'name': 'YANLONG HU, M.D.', 'role': 'CONTACT', 'email': 'doctor_yanlonghu@hotmail.com', 'phone': '86-10-69543901', 'phoneExt': '2055'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Luhe Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}