NCT06281080招募中不适用
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Successful en-bloc tumour resection by the robotic system
研究概览
简要总结
This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Body mass index <35 kg/m2
- •Bladder tumour located <3 cm in size; clinically non-muscle invasive bladder tumour
- •Clinically indicated for en-bloc resection.
- •Willingness to participate as demonstrated by giving informed consent
排除标准
- •Presence of endoscopic or imaging signs of detrusor muscle invasion
- •Contraindication to general anaesthesia / spinal anaesthesia
- •ASA > 2 patients
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Un-corrected coagulopathy
- •Presence of another malignancy or distant metastasis
- •Emergency surgery
- •Vulnerable population (e.g. mentally disabled, pregnant)
结局指标
主要结局
Successful en-bloc tumour resection by the robotic system
时间窗: During the operation
The number of cases completed the intervention by robotic system
次要结局
- Dissection time and speed(During operation)
- Total procedure time(During operation)
- Surgeon Console time(During operation)
- Presence of detrusor muscle in specimen(During operation)
- Resection Margin(During operation)
- Intra-operative bladder perforation event(During operation)
- Post-operative complications(Within 90 days after the study intervention)
- Need of bladder irrigation(Within 30 days after the study intervention.)
- Residual tumour or upstaging of tumour after second look TURBT(Within 30 days after the study intervention.)
研究者
Chi Fai NG
Professor
Chinese University of Hong Kong
研究点 (2)
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