EUCTR2014-000669-39-DK进行中（未招募）1 期
Endoscopic treatment of neoplasia in the upper urinary tract and the value of fluorescence guided endoscopic follow up.
Gregers Gautier Hermann0 个研究点目标入组 20 人开始时间: 2014年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Low grade (WHO grade 1 or 2) tumours in the upper urinary tract.
- •-Patients with urothelial tumours and where RNU (radical nephroureterectomy) cannot be performed (due to one kidney, horseshoe shaped kidney, bilateral disease or co-morbidity which makes bigger surgery impossible)
- •-Tumour limited to renal pelvis and one calyx or limited to two calyxes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Patients with porphyria
- •-Macroscopic haematuria, as it might interfere with the fluorescence guided cysto-ureteroscopy
- •-Known hypersensitivity to 5-ALA or porphyrins
- •-Pregnant or breast-feeding women (women of childbearing age will have a pregnancy test)
- •-Expected poor study compliance
- •-Patients < 18 years
- •-Patients who do not read or understand Danish
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