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临床试验/NCT06976684
NCT06976684尚未招募不适用

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

National Taiwan University Hospital0 个研究点目标入组 20 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization

研究概览

简要总结

Reality (XR)-Assisted CT-Guided Localization

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Patients younger than 18 or older than 80 years.
  • •Patients requiring lobectomy.
  • •Patients who have not provided written informed consent.
  • •Vulnerable populations.

研究组 & 干预措施

Extended Reality (XR)-Assisted CT-Guided Localization

Experimental

干预措施: Extended Reality (XR)-Assisted CT-Guided Localization (Procedure)

结局指标

主要结局

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

时间窗: Immediatedly after 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.

次要结局

  • Assessment of perioperative outcomes(The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.)

研究者

申办方类型
Other
责任方
Sponsor

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