Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital

About this trial

Reality (XR)-Assisted CT-Guided Localization

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 80 who are scheduled to undergo lung nodule resection surgery.

Patients with lung nodules smaller than 2 cm that require preoperative localization.

Patients with lung nodules located in the outer one-third of the lung.

Disqualifiers

Patients younger than 18 or older than 80 years.

Patients requiring lobectomy.

Patients who have not provided written informed consent.

Vulnerable populations.

Trial design

Design model

Single group

Treatments tested in this trial

  • Extended Reality (XR)-Assisted CT-Guided Localization

    Procedure/Surgery

    This study plans to collect approximately 20 localization cases from multiple centers within our hospital. Initially, two sets of preoperative simulated CT scans (at end-inhalation and end-exhalation) will be performed in the CT suite to construct a usable model of the surgical posture and the lesion. Subsequently, in the hybrid operating room, a digital twin model will be applied to the patient using a metaverse platform. Guided by virtual localization lines, percutaneous injection of Patent Blue dye will be carried out at end-exhalation for accurate marking of the lesion. Immediately after the injection, intraoperative CT within the hybrid operating room will be used to verify the localization. If the accuracy is suboptimal (with a deviation greater than 2 cm), standard CT-guided Patent Blue dye localization will be performed as a supplementary measure to complete the localization and proceed with surgery.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Extended Reality (XR)-Assisted CT-Guided LocalizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization

Procedures in this study will be conducted in a hybrid operating room featuring cone-beam CT. The accuracy of XR-assisted CT-guided localization will be assessed immediately post-localization by employing cone-beam CT to ascertain the needle tip position and measure the distance to the target tumor.

Time frame
Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization

Secondary outcomes

1

Assessment of perioperative outcomes

Perioperative outcomes, including but not limited to intraoperative blood loss, localization time, and operative time, will be measured.

Time frame
The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: