NCT03204201终止1 期
Validation of ICG to Identify the Urethra During Rectal Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of urethras identified under white light and fluorescence
研究概览
简要总结
This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male, aged 18 years or above.
- •Undergoing low rectal surgery where the operating field will be close to the urethra
排除标准
- •Participant has an allergy to iodine or ICG
- •Known liver failure
研究组 & 干预措施
Urethral instillation of ICG
Experimental
Urethral instillation of indocyanine green (ICG)
干预措施: Indocyanine Green Solution (Drug)
结局指标
主要结局
Number of urethras identified under white light and fluorescence
时间窗: 1 day
次要结局
- Signal to background ratios between cohorts of patients with varying doses of ICG(1 day)
- Subjective assessment of usefulness of technology during operative procedure(1 day)
- Length of time of interruption in operative procedure to perform trial intervention(1 day)
- Number of adverse events related to trial intervention(30 days)
研究者
Thomas Barnes
Clinical Research Fellow
Oxford University Hospitals NHS Trust
研究点 (1)
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