跳至主要内容
临床试验/NCT02090660
NCT02090660已完成2 期

Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.

研究概览

简要总结

This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence localization technique with a Laser fluorescence thoracoscope system.

The primary objective of this study is to prove the validity and safety of our novel fluorescent localization method with utilized ICG and novel near infra-red fluorescence videoscope system.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.

排除标准

  • Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
  • Pregnant or potentially pregnant women.

研究组 & 干预措施

VATS wedge lung resection

Experimental

干预措施: ICG Localization with Spy thoracoscope localization (Other)

结局指标

主要结局

Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.

时间窗: Within 4 hours of ICG injection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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