Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06976684

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Reality (XR)-Assisted CT-Guided Localization

Detailed description

With the widespread use of computed tomography (CT), lung nodules detected through screening have become increasingly smaller. These small nodules are often hidden within the lung parenchyma, making them difficult to visualize or palpate during surgery. As a result, nodule localization techniques have become critically important and are heavily relied upon by thoracic surgeons. Currently, CT-guided localization is the standard approach; however, this requires patients to move between the CT suite, the ward, and the operating room, which is highly inconvenient. An alternative is the use of a one-stop hybrid operating room, which integrates imaging and surgery in a single space, but this solution is costly. This study aims to enroll 20 patients in a pilot investigation of using extended reality (XR)-guided localization in video-assisted thoracoscopic surgery (VATS) for lung nodule resection. By leveraging current XR technologies, a digital twin model will be superimposed onto the patient's body. Our team-developed virtual localization technique will then be used to mark the tumor site with dye, enabling surgeons to precisely excise the tumor with minimal tissue removal. If successful, this technology has the potential to replace traditional CT-guided or hybrid operating room localization, thereby reducing patient inconvenience and financial burden, and ultimately achieving a streamlined and cost-effective surgical workflow.

Conditions

Interventions

TypeNameDescription
PROCEDUREExtended Reality (XR)-Assisted CT-Guided LocalizationThis 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.

Timeline

Start date
2025-05-01
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2025-05-16
Last updated
2025-05-16

Source: ClinicalTrials.gov record NCT06976684. Inclusion in this directory is not an endorsement.