Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tumour clearance
研究概览
简要总结
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
详细描述
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Study Design: Open prospective study in patients with recurrent pTa low grade bladder tumours.
All patients will have their bladder tumour removed using a diode laser. The treatment will take place in the outpatient department (OPD) without any pain treatment. Biopsy from the tumour will be obtained before the procedure. If the biopsy shows low grade non-invasive bladder tumour, flexible cystoscopy will be repeated one month later in the OPD. At both procedures biopsy will be taken from the laser treated area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Recurrence of pTa low grade urothelial bladder tumor
- •Tumor < 1.5 cm
- •< 6 tumors
排除标准
- •Patients with porphyria
- •Known hypersensitivity to Hexvix® or porphyrins
- •Use of any anticoagulants
- •Macroscopic hematuria
- •Pregnant or breast feeding women
- •Expected poor compliance
- •Patients < 18 years
- •Patients who do not read or understand Danish
结局指标
主要结局
Tumour clearance
时间窗: 1 month
No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.
次要结局
未报告次要终点
研究者
Gregers Gautier Hermann
consultant urologist
University Hospital Bispebjerg and Frederiksberg