Accuracy of the LiverVision® Semi-automated Liver Volumetry Software

NCT ID: NCT03766633

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-29

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Liver 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Diseases Liver Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LiverVision Liver Volumetry Semi-automated Living donor liver transplantation Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Living liver donors

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

Liver volumetry of the graft on CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liver volumetry of the graft on CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults (18 years or older)
* Living liver donors.

Exclusion Criteria

* Recipients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara University

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dimitri Raptis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Massimo Malago', MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dimitri A Raptis, MD, MSc, PhD

Role: CONTACT

Phone: +447584560889

Email: [email protected]

Massimo Malago', MD, PhD

Role: CONTACT

Phone: +442077940500

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Arnold Radke, MD, PhD

Role: primary

Deniz Balci, MD

Role: primary

Massimo Malagò, MD, PhD

Role: primary

Dimitri A Raptis, MD, MSc, PhD

Role: backup

Related Links

Access external resources that provide additional context or updates about the study.

https://LiverVision.org/

Data management platform for the LiverVision.org Study

https://rBiostatistics.com/

Cloud Graphical User Interface for R Statistics, the statistical analysis software

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LV.2018.04.29

Identifier Type: -

Identifier Source: org_study_id