实施Versius机器人手术系统用于胸部手术:首次对可行性和性能进行临床评估
Sara Fra1,2, Usue Caballero-Silva1, Alberto Cabañero-Sánchez1
1Department of Thoracic Surgery, Ramon y Cajal University Hospital, Madrid, Spain.
概括
在2a期研究中,Versius手术系统安全地完成了胸部手术. 肺切除和胸膜切除是可行的,支持进一步的临床试验.
科学领域:
- 机器人手术是一种机器人手术.
- 胸部外科手术 胸部外科手术
- 手术方面的创新.
背景情况:
- 创意,开发,探索,评估和长期跟进 (IDEAL) 框架指导了外科创新.
- 阶段2a侧重于新外科技术的开发阶段.
研究的目的:
- 评估Versius手术系统在胸部手术中的安全性和有效性.
- 在IDEAL 2a阶段框架内评估可行性.
主要方法:
- 对30名连续接受Versius机器人胸部手术的患者进行前性研究.
- 这些手术包括由初学者机器人外科医生进行的25次肺切除和5次胸膜切除.
- 主要结果:安全完成,没有计划外转换;次要结果:并发症,设备相关事件和结果.
主要成果:
- 93.3%的程序在没有转换的情况下成功完成.
- 术后并发症发生在20%的患者中,主要是持续的空气泄漏.
- 没有观察到再入院或死亡率;乳腺切除术没有并发症.
结论:
- 在2a期IDEAL-D研究中,Versius系统可用于肺切除和胸膜切除.
- 这项研究为更大规模的临床试验 (第2b期和第3期) 提供了基础.
- 使用Versius的机器人胸部手术显示出未来发展的前景.
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