NCT06491524已完成不适用
Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm
Ningbo No. 1 Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Success rate of Accessing
研究概览
简要总结
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone <2cm.
详细描述
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral guide sheath to treat renal stone <2cm, and investigating its efficacy and safety.
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
- •Patients with kidney stones less than 2cm who choose to perform "Flexible ureteroscopic holmium laser lithotripsy";
- •Over 18 years old, male or female;
- •No hydronephrosis or mild to moderate hydronephrosis (collection system separation is less than 2cm);
- •The subject has no mental illness or language dysfunction, can understand the situation of this study and has signed an informed consent form, and is estimated to be able to cooperate with the completion of the entire study;
- •No urinary tract infection or no clinical manifestations of urinary tract infection;
- •Patients with urinary tract infection, negative urine culture, and no fever need to undergo antibiotic treatment for more than 3 days; urinary routine examination suggests urinary tract infection, positive urine culture, and patients without fever need to undergo antibiotic treatment for more than 7 days, till the urine culture turns negative.
排除标准
- •Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy;
- •Fever or urinary tract infection is not treated according to the inclusion criteira;
- •Pregnant women and women's menstrual periods;
- •Cannot tolerate anaesthesia or surgery due to serious systemic diseases, heart disease, lung insufficiency and failure of important organs;
- •Anatomical malformations such as polycystic kidneys, horseshoe kidneys, and ectopic kidneys;
- •Patients with high suspicion of ureteral stenosis or diseases that are considered unsuitable to participate in this clinical study;
- •Patients indwelling double J stent preoperatively;
- •Patients who need bilateral upper urinary tract surgery at the same time.
结局指标
主要结局
Success rate of Accessing
时间窗: 1 day
success rate of UAS placement (SRUP)
次要结局
- overactive bladder symptom score (OABSS)(1 month)
- Quality of life (QOL) questionnaire(1 month)
- Evaluation of intraoperative ureteral injury(1 day)
- Stone free rate(1 and 30 days)
研究者
研究点 (1)
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