Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

108

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach

3 countries

3 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

April 29, 2018

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed

Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

December 4, 2018

Last Update Submit

November 18, 2020

Conditions

Liver Diseases Liver Cancer

Keywords

LiverVisionLiverVolumetrySemi-automatedLiving donor liver transplantationSurgery

Outcome Measures

Primary Outcomes (1)

Accuracy of the LiverVision® software volumetric measurements
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).
Baseline (CT performed prior to donation).

Secondary Outcomes (3)

Learning curve of the raters
Baseline (CT performed prior to donation).
Certainty and accuracy of the volumetric measurements.
Baseline (CT performed prior to donation).
Comparison
Baseline (CT performed prior to donation).

Study Arms (1)

Living liver donors

This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.

Diagnostic Test: Liver volumetry of the graft on CT

Interventions

Liver volumetry of the graft on CTDIAGNOSTIC_TEST

Preoperative liver volumetry using the CT images of the potential living liver donors.

Living liver donors

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

Adults (18 years or older)
Living liver donors.

You may not qualify if:

Recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Royal Free Hospital NHS Foundation Trustlead
Ankara Universitycollaborator
University Hospital Tuebingencollaborator
Imperial College Healthcare NHS Trustcollaborator

Study Sites (3)

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver DiseasesLiver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

Massimo Malago', MD, PhD
Royal Free Hospital NHS Foundation Trust
PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitri A Raptis, MD, MSc, PhD

CONTACT

+447584560889 dimitri.raptis@nhs.net

Massimo Malago', MD, PhD

CONTACT

+442077940500 massimo.malago@nhs.net

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 6, 2018

Study Start

April 29, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing: Will not share

Locations

TU(1)GB(1)DE(1)

Accuracy of the LiverVision® Semi-automated Liver Volumetry Software

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Living liver donors

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Living liver donors

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations