Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT06043895
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EpiFaith CV for Central Venous Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The care providers (conducting physicians) and the research assistants who observe and record the results will know the assignments, while the participants and data analysts will not know the assignments.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall surgical time', 'timeFrame': '1 hour', 'description': 'The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle'}], 'secondaryOutcomes': [{'measure': 'Amount of blood drawn', 'timeFrame': '1 hour', 'description': 'The total amount of blood drawn during the procedure'}, {'measure': 'Number of attempts to place guidewire', 'timeFrame': '1 hour', 'description': 'Number of attempts to place guidewire during the procedure'}, {'measure': 'Arterial puncture rate', 'timeFrame': '1 hour', 'description': 'The rate of arterial puncture during the procedure'}, {'measure': 'Arterial puncture identification rate', 'timeFrame': '1 hour', 'description': 'The rate of identification of arterial puncture'}, {'measure': 'Success rate', 'timeFrame': '1 hour', 'description': 'The rate for successful central venous catheterization within 3 attempts'}, {'measure': 'Likert scale for satisfaction', 'timeFrame': '1 hour', 'description': 'Likert scale for satisfaction of using either device for central venous catheterization and qualitative measurement for user experiences'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central Venous Catheterization', 'Patient Safety', 'Visual Feedback', 'Anesthesiology', 'Clinical Skill'], 'conditions': ['Catheterization, Central Venous', 'Equipment Design', 'Patient Safety', 'Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices', 'Perioperative Care']}, 'descriptionModule': {'briefSummary': 'EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.', 'detailedDescription': 'Central venous catheterization (CVC) is crucial in modern perioperative and intensive care. Keeping constant and stable negative pressure while advancing the needle had been issue for beginners. Recently, EpiFaith CV provides a new solution for CVC, which facilitates syringe control and precision during assessing vessels. It provides steady aspiration and detection of arterial pressure as an alternative to manometry without the need to disconnect nor more connections. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (for participants):\n\n* 18 years old and above\n* Surgical patients who need to have a central venous catheter placed\n* Informed and agree to participate in the study\n\nInclusion Criteria (for conducting physicians):\n\n* Physicians with \\>100 central venous catheter placement experience, including attending physicians and senior residents\n\nExclusion Criteria (for participants):\n\n* Patient refusal\n* Puncture site skin lesions\n* Uncorrected coagulation disorder\n* Hemodynamic instability\n* Not informed and consented to participate in research\n\nExclusion Criteria (for conducting physicians):\n\n* Not informed and consented to participate in research'}, 'identificationModule': {'nctId': 'NCT06043895', 'briefTitle': 'EpiFaith CV for Central Venous Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization', 'orgStudyIdInfo': {'id': '202304082DIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EpiFaith CV', 'description': 'The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture', 'interventionNames': ['Device: EpiFaith CV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture', 'interventionNames': ['Device: Conventional']}], 'interventions': [{'name': 'EpiFaith CV', 'type': 'DEVICE', 'description': 'The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.', 'armGroupLabels': ['EpiFaith CV']}, {'name': 'Conventional', 'type': 'DEVICE', 'description': 'The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Man-Ling Wang, MD, PhD', 'role': 'CONTACT', 'email': 'mlwang@ntu.edu.tw', 'phone': '+886-2-2312-3456', 'phoneExt': '262158'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Man-Ling Wang, MD, PhD', 'role': 'CONTACT', 'email': 'mlwang@ntu.edu.tw', 'phone': '+886-2312-3456', 'phoneExt': '262158'}], 'overallOfficials': [{'name': 'Man-Ling Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'There is a plan to make IPD and related data dictionaries available.', 'accessCriteria': 'The PI will review requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}