NCT06524297

Brief Summary

the metaverse system applied to the training of wound location selection for singleport thoracoscopic surgery. The experimental design is two groups of 40 computer tomography located superficially less than 2 cm lung nodule patients, one group uses the metaverse system to let resident physicians simulate the wound position on the digital twin organs of each patient, and the other group does not use it. The investigators will evaluate the surgeon's satisfaction with the surgical wound position and urgicalrelated results (such as surgery time, blood loss, etc.). The investigators expect that the system will help improve the appropriateness of resident physicians' choice of wound location for high-difficulty single-port thoracoscopic surgery, help them cross the first threshold necessary to familiarize themselves with the surgery faster, and accelerate learning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 14, 2025

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 23, 2024

Last Update Submit

May 9, 2025

Conditions

Keywords

MetaverseSurgical EducationSurgical SimulationDigital TwinMixed RealitySingle-Port Thoracoscopy

Outcome Measures

Primary Outcomes (1)

  • Operation time

    Compare the length of operation time between the experimental group (trained using the Metaverse surgical simulation system for 15 minutes pre-operatively) and the control group. This analysis will assess whether pre-operative simulation training reduces operation time for residents.

    24 hours

Secondary Outcomes (1)

  • Satisfaction Questionnaire for Attending Physicians

    Through study completion, an average of 1 year.

Study Arms (2)

Metaverse system

EXPERIMENTAL

Residents use the Metaverse system before surgery to simulate wound closure locations on digital twin organs of the patient.

Other: Metaverse system (Patients)Other: Metaverse system (Resident Physician)

Crontrol group

NO INTERVENTION

The control group do not use the Metaverse system.

Interventions

The experimental group will undergo preoperative training using the metaverse surgical simulation system for 15 minutes before selecting the surgical incision site (this refers to residents receiving the assisted training). The trial process requires participants' consent to provide high-resolution CT images as the basis for reconstructing digital twin organs. Except for the intervention training, the surgery, postoperative care, follow-up, and other treatment processes the participants receive will be the same as those for typical patients.

Metaverse system

The participants (residents) will receive 15 minutes of preoperative training using the Metaverse surgical simulation system. They will superimpose the digital twin model onto the patient on the operating table and use the CT cross-sectional matching function within the Metaverse system to locate the lesion. The participants (residents) can use the system to repeatedly simulate incision sites and mark planned entry points on the patient by overlaying the virtual model onto the real patient. Except for the intervention training with the system, the subsequent surgery, postoperative care, follow-up, and other treatment processes the patients receive will be the same as usual.

Metaverse system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older.
  • Diagnosed with a lung nodule no larger than 2cm in diameter. The lesion depth must be located within the outer third of the lung.
  • Scheduled to undergo computer tomography-guided single-port thoracoscopic wedge resection at National Taiwan University Hospital (NTUH) or National Taiwan Cancer Center (NTUCC).
  • Participants who have provided written informed consent for their imaging data to be used by the team to create digital twin models.

You may not qualify if:

  • Patients with lesions larger than 2 cm.
  • Patients not planned for single-port thoracoscopic wedge resection with computed tomography localization.
  • Patients who have not provided written consent.
  • Members of vulnerable populations.
  • Third-year to fifth-year residents in the Department of Thoracic Surgery at National Taiwan University Hospital.
  • Residents who are unwilling to participate in the study and decline to sign the consent form.
  • Residents with a history of cybersickness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xu-Heng Chiang, MD

    Department of Surgery, National Taiwain University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiang

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

August 15, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

May 14, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share