Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of signal to background measurements and visualisation of fluorescence in the ureter
研究概览
简要总结
Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous IRDye 800BK
Patients undergoing laparoscopic bowel resection & laparoscopic donor nephrectomy
干预措施: Intravenous IRDye 800BK (Drug)
结局指标
主要结局
Change of signal to background measurements and visualisation of fluorescence in the ureter
时间窗: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Signal to background is an objective measurement of fluorescence signal
Change in subjective assessment of ureter visualisation with and without fluorescence
时间窗: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
次要结局
- Number of adverse events related to IRDye 800BK administration(30 days post administration)
研究者
Thomas Barnes
Clinical Research Fellow
Oxford University Hospitals NHS Trust