Image Guided VATS Resection vs. VATS Resection of Lung Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Operating Room Time
研究概览
简要总结
To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.
详细描述
This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18 years and older
- •Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon
- •Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm
- •Subject's lesions that are located in the outer half portion of the lung/lobe.
- •Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics
排除标准
- •If participant is a pregnant woman or breast feeding they will not be eligible.
- •If treating thoracic surgeon deems the participant not eligible for the study.
结局指标
主要结局
Operating Room Time
时间窗: 3 years to complete
The time (in min.) from incision to close
次要结局
- Time for induction to incision(3 years)
- Radiation Exposure(3 years)
- Time to T-bar placement(3 years)
- Hospital Length of Stay(3 years)
研究者
Raphael Bueno
Chief of Throacic Surgery
Brigham and Women's Hospital