NCT07595120尚未招募不适用
Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial
Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026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
- 发起方
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, regardless of gender;
- •Solitary single nodule, scheduled for lung nodule puncture and localization;
- •Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm;
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
- •Voluntary participation, with signed informed consent.
排除标准
- •Not suitable for video-assisted thoracoscopic surgery;
- •The distance between the center of the lesion and the dome of the diaphragm is < 3 cm;
- •History of thoracic adhesion due to previous thoracotomy or pleural infection;
- •Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization;
- •Inability to complete follow-up or poor compliance.
研究组 & 干预措施
Electromagnetic Navigation Localization Group
Experimental
干预措施: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules (Procedure)
CT-Guided Localization Group
Active Comparator
干预措施: CT-Guided Percutaneous Localization of Pulmonary Nodules (Procedure)
研究者
Haifeng Wang
Prof.
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
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