Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-08 @ 4:26 AM
Study NCT ID:
NCT03766633
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the LiverVision® Semi-automated Liver Volumetry Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the LiverVision® software volumetric measurements', 'timeFrame': 'Baseline (CT performed prior to donation).', 'description': 'Accuracy of the LiverVision® software volumetric measurements assessed by correlation and agreement statistics with the manual volumetric measurements as well as the actual graph weight (reference standard).'}], 'secondaryOutcomes': [{'measure': 'Learning curve of the raters', 'timeFrame': 'Baseline (CT performed prior to donation).', 'description': 'Assessment of the learning curve of the raters when using LiverVision® software assessed by the time required for the volumetric measurements and the accuracy of the results.'}, {'measure': 'Certainty and accuracy of the volumetric measurements.', 'timeFrame': 'Baseline (CT performed prior to donation).', 'description': 'Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.'}, {'measure': 'Comparison', 'timeFrame': 'Baseline (CT performed prior to donation).', 'description': 'Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LiverVision', 'Liver', 'Volumetry', 'Semi-automated', 'Living donor liver transplantation', 'Surgery'], 'conditions': ['Liver Diseases', 'Liver Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://LiverVision.org/', 'label': 'Data management platform for the LiverVision.org Study'}, {'url': 'https://rBiostatistics.com/', 'label': 'Cloud Graphical User Interface for R Statistics, the statistical analysis software'}]}, 'descriptionModule': {'briefSummary': 'The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools.', 'detailedDescription': 'Liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively.\n\nLiver volumetry is typically performed using CT imaging with specially designed software. Such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive living liver donors that underwent a CT prior to liver donation. The raters will be 6 surgeons and 6 radiologists, both junior and senior.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or older)\n* Living liver donors.\n\nExclusion Criteria:\n\n* Recipients'}, 'identificationModule': {'nctId': 'NCT03766633', 'acronym': 'LiverVision', 'briefTitle': 'Accuracy of the LiverVision® Semi-automated Liver Volumetry Software', 'organization': {'class': 'OTHER', 'fullName': 'Royal Free Hospital NHS Foundation Trust'}, 'officialTitle': 'Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation', 'orgStudyIdInfo': {'id': 'LV.2018.04.29'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Living liver donors', 'description': 'This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.', 'interventionNames': ['Diagnostic Test: Liver volumetry of the graft on CT']}], 'interventions': [{'name': 'Liver volumetry of the graft on CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative liver volumetry using the CT images of the potential living liver donors.', 'armGroupLabels': ['Living liver donors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arnold Radke, MD, PhD', 'role': 'CONTACT', 'email': 'arnoldradke@yahoo.de', 'phone': '+497071290'}], 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '06620', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Deniz Balci, MD', 'role': 'CONTACT', 'email': 'denizbalci1@yahoo.com', 'phone': '+903125956000'}], 'facility': 'Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': 'NW3 2QG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Massimo Malagò, MD, PhD', 'role': 'CONTACT'}, {'name': 'Dimitri A Raptis, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'dimitri.raptis@nhs.net', 'phone': '+447584560889'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Dimitri A Raptis, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'dimitri.raptis@nhs.net', 'phone': '+447584560889'}, {'name': "Massimo Malago', MD, PhD", 'role': 'CONTACT', 'email': 'massimo.malago@nhs.net', 'phone': '+442077940500'}], 'overallOfficials': [{'name': "Massimo Malago', MD, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Free Hospital NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan for sharing individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Free Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara University', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dimitri Raptis', 'investigatorAffiliation': 'Royal Free Hospital NHS Foundation Trust'}}}}