ChiCTR2500099376已完成Unknown
Evaluation of the HugeMed HU30M Single-Use Ureteroscope for Kidney Stone Treatment: A Prospective Clinical Study
未提供1 个研究点 分布在 1 个国家开始时间: 2024年2月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Stone-Free Rate (SFR) at 30 Days
研究概览
简要总结
To compare the clinical outcomes of the 6.3 Fr single-use flexible ureteroscope (HugeMed HU30M) versus the standard 7.5 Fr single-use ureteroscope in the treatment of kidney stones ≤ 2 cm. Primary outcome: stone-free rate (SFR) at 30 days postoperatively. Secondary outcomes: operative time, laser energy efficiency, and complication rates (Clavien-Dindo classification).
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Age <= 75 years;
- •Diagnosed with kidney stones <= 2 cm confirmed by CT;
- •Pre-stented before surgery;
- •Able to attend follow-up at 30 days.
排除标准
- •Presence of ureteral stones only (without kidney stones);
- •Active urinary tract infection (positive urine culture);
- •Oncological patients with urological malignancies;
- •Severe comorbidities preventing safe anesthesia or surgery;
- •Patients unable to comply with follow-up requirements.
研究组 & 干预措施
Group 1 (Experimental Group)
Group: Standard Ureteroscope (7.5 Fr)
结局指标
主要结局
Stone-Free Rate (SFR) at 30 Days
时间窗: 30 days postoperatively
次要结局
- Operative Time(During surgery)
- Postoperative Complication Rate (Clavien-Dindo Classification)(During hospital stay and at 30-day follow-up)
- Laser Energy Consumption(During surgery)
研究者
研究点 (1)
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