EUCTR2012-001381-15-DK进行中（未招募）1 期
Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial
Sahlgrenska University Hospital Västra Götalandsregionen0 个研究点目标入组 80 人开始时间: 2014年9月23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
- 80
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
- •-Provision of informed consent prior to any study specific procedures
- •- Female or male aged 18-80 years
- •- Intended curative radiation of the pelvic region as a treatment for cancer
- •- End of radiation therapy more than 6 months ago
- •- Radiation cystitis with Urological EPIC < 80
- •-Radiation cystitis is the most probable cause for the patient’s symptoms
- •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 20
- •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 major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
- •- Refractory incontinence requiring catheter or surgical intervention
- •- Urine bladder capacity < 100ml
- •- Fistula in the urine bladder
- •- Contraindications for HBO therapy according to the local centres routines
- •- Pregnancy
- •- Mechanical ventilator support
- •- Unable to follow and understand simple commands
- •- Not oriented to person, place and time
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