EUCTR2016-003813-92-IT进行中（未招募）1 期
Open clinical trial to evaluate the efficacy of intravesical instillation of hyaluronate added to early instillation of mitomycin vs early instillation of mitomycin in patients suffering from low risk not muscle-infiltrating bladder cancer - Efficacy of hyaluronate/condroitinsolfate (Ialuril Prefill) added on top of Mitomycin C vs Mitomy
IBSA FARMACEUTICI ITALIA SR0 个研究点目标入组 120 人开始时间: 2018年2月22日最近更新:
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
- 120
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
- •Both gender with 18-80 years of age
- •Physiological/Surgical Menopause
- •Histological diagnosis of transitional vesical neoplasia
- •Patients with vesical neoplasia at low risk according to EORTC
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Hypersensitivity either to Ialurill Prefill or to one of its component
- •Hypersensitivity and controindications to Mitomycin C
- •Ongoing macroematuria
- •Suspected bladder drill
- •Patients with vesical neoplasia at high risk according to EORTC
- •Capacity of bladder < 300 cc
研究者
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