Feasibility and Efficacy of Surgical Navigation 'RUS Lung' in Patients Undergoing Minimally Invasive Thoracic Surgery (MITS) Segmentectomy for Lung Cancer: a Multicenter Prospective Observational Study With a Propensity-score Matching Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The concordance rate of tumor location across CT, RUS Lung, and surgery
研究概览
简要总结
This sponsor-initiated prospective observational study aims to demonstrate the feasibility and efficacy of RUS Lung Surgical Navigation System in patients undergoing minimally invasive thoracic surgery(MITS). The trial will enroll 36 patients who undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung. The study will be conducted across two medical centers."
- Investigational Medical Device: RUS Lung (Endoscopic Imaging Treatment Planning Software)
- Clinical Trial duration: 12 months from IRB approval
- Target number of subjects: Total of 36 participants
详细描述
Patients will be enrolled after being selected based on the inclusion and exclusion criteria and after obtaining informed consent. Video-assisted or robot-assisted thoracic surgery (VATS/RATS) will be performed using RUS Lung.Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 2 weeks after discharge. The operative outcomes including operative time, estimated blood loss, complication rates, and hospital length were compared with the historical control underwent VATS and RATS without using RUS Lung.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who were diagnosed with lung caner (tumor size≤3cm)
- •Individuals aged 19 or older
- •Individuals who who are able to undergo CT imaging according to the established protocol
- •Individuals who have voluntarily given written consent to participate in this clinical trial
排除标准
- •Vulnerable subjects
- •Individuals who who are not able to undergo CT imaging according to the established protocol
- •Individuals who are expected to have severe adhesions
- •Individuals who are unable to follow the study procedures and are deemed inappropriate for participation
结局指标
主要结局
The concordance rate of tumor location across CT, RUS Lung, and surgery
时间窗: The operative day (operative day ± 5 days)
Overall feasibility of the RUS Lung system will be evaluated by 3 factors as below. 1. CT turn-around time: the duration between uploading of preoperative CT and downloading the 3D model file 2. The stability of the RUS Lung system 3. The concordance rate of tumor location across CT, RUS Lung, and surgery
次要结局
- The degree of consistency between surgical planning using the RUS lung system and actual surgical findings.(From enrollment to the end of treatment at 2 weeks)