Virtual RealityMetaverseNCT06513143
Metaverse Surgical Simulation Platform
An observational study of Virtual Reality, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This project aims to combine virtual reality (VR) technologies to construct a metaverse simulation lung surgery platform, which can not only be used as equipment for training novices, but also as a simulated rehearsal before actual surgery, to improve the safety and smoothness of difficult surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality
- What is being tested?
- CT images into virtual 3D model demonstration
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed by surgeons with the following conditions will be included in the eligible group: 1. Complex thoracic surgery, 2. Large mediastinal tumors, 3. Interpulmonary tumors, 4. Patients requiring tracheal transplantation.
Who may be able to join
- Physicians assess suitable candidates.
- Consent to the use of their high-resolution computed tomography (CT) scan results as digital simulation material for the establishment of a virtual reality surgical platform.
Who cannot join
- Those without high-resolution computed tomography (CT) scan results.
- Any conditions and circumstances that the trial principal investigator believes may affect the establishment of the trial platform.
- Those who have concerns about providing their own CT data.
- (For trial user) The exclusion criteria are:
- (1) Individuals under the age of 18 are excluded.
- (2) Any condition or circumstance that the principal investigator deems may affect the establishment of the trial platform.
- (3) Those who have concerns about providing their own data related to using the surgical simulation platform.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Surgery, National Taiwain University Hospital
Taipei, 100
Xu-Heng Chiang, MD, 0972655136, lycansblueray@gmail.com
About this study
This project aims to combine virtual reality (VR) technologies to construct a metaverse simulation lung surgery platform, which can not only be used as equipment for training novices, but also as a simulated rehearsal before actual surgery, to improve the safety and smoothness of difficult surgeries.
Read the detailed description
During the training process of surgeons, hands-on operation has always been the highest guiding principle. Even the most basic and simple surgery requires actual operation before it can be truly learned. However, today, with the increasing awareness of patients, it is slowly becoming unfeasible to let novices directly use patients as practice subjects. In addition to being subject to medical ethics, patients are increasingly unwilling to act as guinea pigs for novice surgeons to practice on, so the time it takes for surgeons to mature their surgical skills is getting longer and longer. The metaverse simulation surgery training platform that this project aims to create hopes to train novices through maximized simulation, feedback on hand feel and force, coordination of instruments and other essentials of mature surgeons.
Currently, when the investigators face difficult surgeries, the investigators have many preoperative simulation images (such as Fujifilm's Synapse, Figure 1), as well as intraoperative navigation technology to guide the surgery through the reconstructed physiological structure map. To a certain extent, this is also the prototype of the metaverse surgery platform, but the investigators can do better. Because these simulation tools are currently only auxiliary in nature, such as constructing visible 3D images to let us know the location of the tumor and the relative position of important neighboring organs. In the end, the investigators still have to simulate these auxiliary images in our brains. Not only is there no actual operation, but due to the different experiences of each surgeon, the results of "brain simulation" will also be different. Therefore, such simulations lack reproducibility and are not completely objective. Therefore, the investigators are trying to create a metaverse simulation surgery system so that preoperative simulations and rehearsals can have the greatest degree of realism, precision and objectivity.
- Conditions
- Virtual Reality
- Being tested
- CT images into virtual 3D model demonstration
- Keywords
- virtual reality (VR), metaverse, digital twins, simulated surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT images into virtual 3D model demonstrationOther
The investigators have finished is personalized 3D model translation from CT images into virtual 3D model demonstrated in VR glasses using Synapse.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality surgery | The investigators have completed the translation of personalized 3D models from CT images into virtual 3D models displayed on VR glasses using Synapse (Fujifilm). Additionally, the investigators can illustrate reference CT scans, chart summaries, laboratory data, and other medical information within the VR environment. Receives: Other: CT images into virtual 3D model demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaires
To evaluate the satisfaction levels of students or operators
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu-Heng Chiang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513143
- Sponsor's protocol ID
- 202305019RINC
- Acronym
- Metaverse
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metaverse Surgical Simulation Platform
- ClinicalTrials.gov ID
- NCT06513143
- Acronym / sponsor ID
- Metaverse / 202305019RINC
- Conditions
- Virtual Reality
- Keywords
- virtual reality (VR), metaverse, digital twins, simulated surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
This project aims to combine virtual reality (VR) technologies to construct a metaverse simulation lung surgery platform, which can not only be used as equipment for training novices, but also as a simulated rehearsal before actual surgery, to improve the safety and smoothness of difficult surgeries.
Detailed description
During the training process of surgeons, hands-on operation has always been the highest guiding principle. Even the most basic and simple surgery requires actual operation before it can be truly learned. However, today, with the increasing awareness of patients, it is slowly becoming unfeasible to let novices directly use patients as practice subjects. In addition to being subject to medical ethics, patients are increasingly unwilling to act as guinea pigs for novice surgeons to practice on, so the time it takes for surgeons to mature their surgical skills is getting longer and longer. The metaverse simulation surgery training platform that this project aims to create hopes to train novices through maximized simulation, feedback on hand feel and force, coordination of instruments and other essentials of mature surgeons.
Currently, when the investigators face difficult surgeries, the investigators have many preoperative simulation images (such as Fujifilm's Synapse, Figure 1), as well as intraoperative navigation technology to guide the surgery through the reconstructed physiological structure map. To a certain extent, this is also the prototype of the metaverse surgery platform, but the investigators can do better. Because these simulation tools are currently only auxiliary in nature, such as constructing visible 3D images to let us know the location of the tumor and the relative position of important neighboring organs. In the end, the investigators still have to simulate these auxiliary images in our brains. Not only is there no actual operation, but due to the different experiences of each surgeon, the results of "brain simulation" will also be different. Therefore, such simulations lack reproducibility and are not completely objective. Therefore, the investigators are trying to create a metaverse simulation surgery system so that preoperative simulations and rehearsals can have the greatest degree of realism, precision and objectivity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality surgery | – | Other: CT images into virtual 3D model demonstrationThe investigators have completed the translation of personalized 3D models from CT images into virtual 3D models displayed on VR glasses using Synapse (Fujifilm). Additionally, the investigators can illustrate reference CT scans, chart summaries, laboratory data, and other medical information within the VR environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed by surgeons with the following conditions will be included in the eligible group: 1. Complex thoracic surgery, 2. Large mediastinal tumors, 3. Interpulmonary tumors, 4. Patients requiring tracheal transplantation.
Key inclusion criteria (2 listed)
- Physicians assess suitable candidates.
- Consent to the use of their high-resolution computed tomography (CT) scan results as digital simulation material for the establishment of a virtual reality surgical platform.
Key exclusion criteria (7 listed)
- Those without high-resolution computed tomography (CT) scan results.
- Any conditions and circumstances that the trial principal investigator believes may affect the establishment of the trial platform.
- Those who have concerns about providing their own CT data.
- (For trial user) The exclusion criteria are:
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 |
|---|---|---|
| CT images into virtual 3D model demonstrationThe investigators have finished is personalized 3D model translation from CT images into virtual 3D model demonstrated in VR glasses using Synapse. | Other | Virtual reality surgery |
Primary outcome
questionnaires
Time frame: Through study completion, an average of 1 year.
To evaluate the satisfaction levels of students or operators
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
Xu-Heng Chiang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virtual Reality, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu-Heng Chiang, MD (0972655136, lycansblueray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaires (time frame: Through study completion, an average of 1 year.). 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 24 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.