Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05519618
Status:
UNKNOWN
Last Update Posted:
2022-08-29
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-25', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidural venous pressure', 'timeFrame': 'During the embolization intervention.', 'description': 'Epidural venous pressure measured with pressure wire after reach the targeted location, before embolization and after embolization during the embolization procedure.'}, {'measure': 'Epidural venous flow rate.', 'timeFrame': 'During the embolization intervention.', 'description': 'Epidural venous flow rate measured with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.'}], 'secondaryOutcomes': [{'measure': 'Size of epidural venous plexus.', 'timeFrame': 'During the embolization intervention.', 'description': 'Measuring the size of epidural venous plexus with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spine tumor', 'Venous pressure', 'Internal vertebral venous plexus', 'Epidural venous plexus'], 'conditions': ['Neoplasms', 'Spine Tumor', 'Venous Hypertension']}, 'descriptionModule': {'briefSummary': 'Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. The major bleeding point during operation including tumor parenchyma, arteries that are difficult to ligate, and epidural venous plexus. Vascularity of tumor parenchyma had been associated with increased intraoperative blood loss, on the other hand, there is a lack in the literature regarding to evaluation of the size, flow and pressure of epidural venous plexus, and their changes after embolization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who are suspected to have spine tumor, and referred to the multi-discipline spine oncology team in the study institute, for evaluation of debulking surgery or en bloc resection of the spinal tumor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.\n2. The tumor has to be located in thoracic or lumbar spine.\n\nExclusion Criteria:\n\n1. Confirmed non-tumor diagnosis.\n2. Patient who cannot tolerate the procedure due to severe pain.\n3. Patients who cannot receive angiography or embolization due to contraindications, including poor renal function (Serum creatinine \\>2.0 deciliter/mg or estimated glomerular filtration rate(eGFR)) \\< 30ml/min) , severe allergy to contrast medium, uncorrectable coagulopathy and bleeding diathesis.\n4. Patient who has severe neurological deficit that should receive emergent decompression.\n5. Poor image quality.\n6. Expected life expectancy \\< 6 months.'}, 'identificationModule': {'nctId': 'NCT05519618', 'briefTitle': 'Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus', 'orgStudyIdInfo': {'id': '202112207RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'Patient planned to receive debulking or en bloc resection of vertebral tumor.', 'interventionNames': ['Procedure: Epidural veins pressure and flow measurement']}], 'interventions': [{'name': 'Epidural veins pressure and flow measurement', 'type': 'PROCEDURE', 'description': 'The purpose of this study is to measure to pressure and flow of epidural venous plexus.\n\nThe procedure will be performed alongside during pre-operative embolization at the angiography suite.\n\nIt will be performed under general anesthesia. A the start of the procedure, a venous access will be established at the inguinal region. Co-axial catheters will be navigated to epidural venous plexus under the guidance of fluoroscopy. After the placement of catheter, the pressure and flow of epidural venous plexus will be measured at three time points: 1. Right after catheter reach the targeted location 2. Right before embolization. 3. After embolization. The participant will be instructed to control their breathe during measurement.\n\nAfter measurement, the catheter will be removed alongside with embolization devices, and achieved hemostasis as routine.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'YuCheng Huang, M.D.', 'role': 'CONTACT', 'email': 'squll1peter@gmail.com', 'phone': '+886223123456', 'phoneExt': '262570'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'YuCheng Huang, M.D.', 'role': 'CONTACT', 'email': 'squll1peter@gmail.com', 'phone': '+886223123456', 'phoneExt': '262570'}], 'overallOfficials': [{'name': 'YuCheng Huang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}