Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections

NCT ID: NCT06049836

Last Updated: 2024-02-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-02-01

Brief Summary

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The goal of this trial is to compare the evaluation of 3D liver models visualised as holograms with HoloLens 2 and on digital PDF files in HPB surgical trainees.

The main questions it aims to answer are:

* Do the holographic models allow a superior accuracy in terms of anatomical evaluation and surgical planning?
* Is there any difference in terms of time consumed and Task Load Index? Participants will analyse cases through both modalities and answer a questionnaire.

Detailed Description

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Conditions

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Hepatobiliary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Group A analyses 15 patient cases 3D Hologram models (first stage) and after the washout period the same 15 patients cases (anonymised, renamed and shuffled) in liver 3D models on computer monitor visualisation (PDF) (second stage)

Group Type EXPERIMENTAL

Holograms

Intervention Type OTHER

Clinical decision making based on visualising liver 3D holographic augmented reality liver models

PDF

Intervention Type OTHER

Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

Group B

Group B analyses 15 patient cases liver 3D models on computer monitor visualisation (PDF) (first stage) and after the washout period the same 15 patients cases (anonymised, renamed and shuffled) on 3D Hologram models (second stage)

Group Type EXPERIMENTAL

Holograms

Intervention Type OTHER

Clinical decision making based on visualising liver 3D holographic augmented reality liver models

PDF

Intervention Type OTHER

Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

Interventions

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Holograms

Clinical decision making based on visualising liver 3D holographic augmented reality liver models

Intervention Type OTHER

PDF

Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* General Surgery Trainees with at least 6 months experience in HPB surgery

Exclusion Criteria

* No informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)

UNKNOWN

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Rompianesi

Assistant Professor of Surgery - MD, PhD, FEBS (HPB, Transplantation)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto I Troisi, MD PhD FEBS

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Federico II University

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FIICNRHoloLiver

Identifier Type: -

Identifier Source: org_study_id

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