JPRN-jRCT1032220620招募中2 期
A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection - Trial of Evaluating of Air Leakage using Staple Line Reinforcements
Suzuki Hidemi0 个研究点目标入组 120 人开始时间: 2023年2月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 90age old（—）
- 性别
- All
入选标准
- •1) 18 to 90 years of age
- •2) Anatomical pulmonary resection (lobectomy or segmentectomy) using an automated suturing device is planned.
- •3) Patient is considered to have lobar insufficiency on preoperative chest CT and is considered to require an automated suturing device for pulmonary resection.
- •4) ECOG performance status (PS) is 0-1.
- •5) Main organ function is preserved.
- •6) The patient's consent to participate in this study has been obtained in writing.
排除标准
- •1) Wedge resection.
- •2) Patient with multiple lobectomy or segmentectomy that will not result in en bloc resection.
- •3) Patient who is considered to be completely lobulated on preoperative chest CT and is considered not to require an automated suturing device for pulmonary resection.
- •4) Patient with dementia or other conditions that require consent from legally authorized representative
- •5) Patients who may exhibit allergic reactions to the device to be used.
- •6) Patients deemed by the investigator to be unsuitable for the safe conduct of this study
研究者
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