Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 6:50 AM
Study NCT ID:
NCT06642532
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-10-13', 'studyFirstSubmitQcDate': '2024-10-13', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transcranial doppler ultrasonography parameters before and after cranioplasty', 'timeFrame': '6 months', 'description': "transcranial doppler ultrasonography's hemodynamic parameters: Pulse Index（PI） of middle cerebral artery(MCA), terminal internal carotid artery(TICA), anterior communicating artery(ACA), and posterior cerebral artery(PCA) from bilateral temporal window before and after polyetheretherketone cranioplasty. PI=（Vs - Vd ）/ Vm。"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cranial Defect', 'TCD']}, 'descriptionModule': {'briefSummary': 'Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Age of 18 years or older;\n2. Proposed polyetheretherketone cranioplasty;\n3. Incomplete cranial bone in the lateral temporal window.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of 18 years or older;\n2. Proposed polyetheretherketone cranioplasty;\n3. Incomplete cranial bone in the lateral temporal window;\n4. Signed informed consent for surgery and informed consent for research.\n\nExclusion Criteria:\n\n1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.'}, 'identificationModule': {'nctId': 'NCT06642532', 'briefTitle': 'A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty', 'orgStudyIdInfo': {'id': 'LY2024-093-B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TCD group', 'type': 'DEVICE', 'description': 'Transcranial Doppler ultrasound to examine bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Feng, MD, PhD', 'role': 'CONTACT', 'email': 'fengjfmail@163.com', 'phone': '86-21-68383707'}, {'name': 'Yanqing Ni, MD', 'role': 'CONTACT', 'email': 'pd120xz@126.com', 'phone': '86-21-68383707'}, {'name': 'Qing Mao, MD, PhD', 'role': 'CONTACT'}, {'name': 'Junfeng Feng, MD, PhD', 'role': 'CONTACT'}, {'name': 'Ru Gong, MD', 'role': 'CONTACT'}, {'name': 'Jiyuan Hui, MD', 'role': 'CONTACT'}, {'name': 'Ke Cao, MD', 'role': 'CONTACT'}], 'facility': 'Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Feng', 'role': 'CONTACT', 'phone': '+8613611860825'}], 'facility': 'Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Junfeng Feng', 'role': 'CONTACT', 'email': 'fengjfmail@163.com', 'phone': '13611860825'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Director of Brain Injury Center', 'investigatorFullName': 'Junfeng Feng', 'investigatorAffiliation': 'RenJi Hospital'}}}}