Hepatobiliary NeoplasmNCT06049836
Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections
A study testing Holograms and PDF in people with Hepatobiliary Neoplasm, run by Federico II University at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatobiliary Neoplasm
- What is being tested?
- Holograms and PDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General Surgery Trainees with at least 6 months experience in HPB surgery
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hepatobiliary Neoplasm
- Being tested
- Holograms, PDF
- Keywords
- Liver surgery, Preoperative planning, 3D rendering, Augmented reality, Holograms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HologramsOther
Clinical decision making based on visualising liver 3D holographic augmented reality liver models
PDFOther
Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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) Receives: Other: Holograms; Other: PDF |
| Group B | Experimental | 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) Receives: Other: Holograms; Other: PDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic and planning accuracy
Correctly identify anatomy and appropriate surgical planning Residents' decision-making accuracy when reviewing patient data and 3D liver models using Holograms or on PDF, measured by comparing their performance.
The measurement tool will be a questionnaire consisting of 11 questions, rate of correct answers will be recorded (e.g. 8/10 correct answers) and higher scores mean a better outcome.
Measured: Immediately after completing the evaluation
Secondary outcomes (2)
Time consumed
Analyse the time spent for the evaluation of the cases and complete the questionnaire Assessed by total time needed to make decision for 15 patient cases in minutes
Measured: Immediately after completing the evaluation
NASA Task Load Index
Analyse the NASA TLI score for each participant to evaluate the cases by conducting a subjective mental workload assessment rating performance across six dimensions to determine an overall workload rating:
- Mental demand - how much thinking, deciding, or calculating was required to perform the task.
- Physical demand - the amount and intensity of physical activity required to complete the task.
- Temporal demand - the amount of time pressure involved in completing the task.
- Effort - how hard does the participant have to work to maintain their level of performance?
- Performance - the level of success in completing the task.
- Frustration level - how insecure, discouraged, or secure or content the participant felt during the task.
Each participant gives a rating for each subscale from 1 (low) to 20 (high) and the TLX will calculate the overall worklaod score between 0 and 100
Measured: Immediately after completing the evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Oct 2023
- Primary completion30 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)
- Responsible party
- Principal investigator, Gianluca Rompianesi, Federico II University
- Investigators
- Roberto I Troisi, MD PhD FEBS, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049836
- Sponsor's protocol ID
- FIICNRHoloLiver
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD are to be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections
- ClinicalTrials.gov ID
- NCT06049836
- Acronym / sponsor ID
- FIICNRHoloLiver
- Conditions
- Hepatobiliary Neoplasm
- Keywords
- Liver surgery, Preoperative planning, 3D rendering, Augmented reality, Holograms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Holograms, Other: PDFGroup 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 B | Experimental | Other: Holograms, Other: PDFGroup 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General Surgery Trainees with at least 6 months experience in HPB surgery
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HologramsClinical decision making based on visualising liver 3D holographic augmented reality liver models | Other | Group A, Group B |
| PDFClinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file | Other | Group A, Group B |
Primary outcome
Diagnostic and planning accuracy
Time frame: Immediately after completing the evaluation
Correctly identify anatomy and appropriate surgical planning Residents' decision-making accuracy when reviewing patient data and 3D liver models using Holograms or on PDF, measured by comparing their performance. The measurement tool will be a questionnaire consisting of 11 questions, rate of correct answers will be recorded (e.g. 8/10 correct answers) and higher scores mean a better outcome.
2 secondary outcomes
Time consumed
Time frame: Immediately after completing the evaluation
NASA Task Load Index
Time frame: Immediately after completing the evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. All collected IPD are to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto I Troisi, MD PhD FEBS principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holograms and PDF in people with Hepatobiliary Neoplasm, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic and planning accuracy (time frame: Immediately after completing the evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.