NCT06257368招募中不适用
TFL-DUST Study TFL Driven Urinary System Treatment Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 373
- 试验地点
- 5
- 主要终点
- Time in Laser ON
研究概览
简要总结
The goal of this observational study is:
To assess the use of Coloplast TFL Drive in daily practice
To confirm:
- the safety and efficacy of the Coloplast TFL Drive and its GUI (Graphical User Interface) with pre-embedded settings in Laser lithotripsy
- the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia
- the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for ablation of urological tumors
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Any adult patient, for which TFL laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, BPH (Benign Prostate Hypertrophy...)
排除标准
- •Any condition when TFL laser should not be indicated as per the TFL user manual (untrained surgeon on laser use, patient's conditions)
- •Patients with no signed consent form
- •Patients <18 years old
- •Patients under tutorship or guardianship
- •Patients who already took part in the study
- •Pregnant or breastfeeding women
- •Patient undergoing 2nd step laser procedure at inclusion
- •Subject already included in another study
结局指标
主要结局
Time in Laser ON
时间窗: day 1
次要结局
未报告次要终点
研究者
研究点 (5)
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