- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06513143
Metaverse Surgical Simulation Platform (Metaverse)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xu-Heng Chiang, MD
- Phone Number: 0972655136
- Email: lycansblueray@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- Department of Surgery, National Taiwain University Hospital
-
Contact:
- Xu-Heng Chiang, MD
- Phone Number: 0972655136
- Email: lycansblueray@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients diagnosed by surgeons with the following conditions will be included in the eligible group:
- Complex thoracic surgery,
- Large mediastinal tumors,
- Interpulmonary tumors,
- Patients requiring tracheal transplantation.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
The investigators have finished is personalized 3D model translation from CT images into virtual 3D model demonstrated in VR glasses using Synapse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaires
Time Frame: Through study completion, an average of 1 year.
|
To evaluate the satisfaction levels of students or operators
|
Through study completion, an average of 1 year.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xu-Heng Chiang, MD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202305019RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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