Prospective, Single-Site, Single-Arm Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in total procedure time versus a pre-specified benchmark
研究概览
简要总结
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
详细描述
The aim of the study is to prospectively evaluate the operational efficiency and safety of the Veloxion™ disposable resectoscope system when used for endoscopic surgical treatment of benign prostatic hyperplasia. Subjects will be followed up on 2 weeks (phone/clinic) and 1 month, (phone/clinic, safety assessments, device-related AEs, reinterventions, usability feedback).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 30-70 years old with symptomatic BPH.
- •Prostate volume 20-120 mL (TRUS/MRI/US)
- •Suitable for endoscopic resection/vaporization per device IFU.
- •Able to consent and comply with follow-up to 1 month.
排除标准
- •Known/suspected prostate cancer requiring oncologic management.
- •Prior prostate surgery impacting urethral anatomy within 12 months.
- •Prior implant affecting urethral anatomy.
- •Active UTI or untreated bacteriuria pre-op.
- •Uncorrectable coagulopathy; inability to manage antithrombotics.
- •Severe medical comorbidity precluding anesthesia or endoscopy.
研究组 & 干预措施
Aulea Veloxion™ Disposable Resectoscope System
干预措施: Aulea Veloxion™ Disposable Resectoscope System (Device)
Aulea Veloxion™ Disposable Resectoscope System
干预措施: TURP using the Aulea Veloxion™ Disposable Resectoscope System (Procedure)
结局指标
主要结局
Difference in total procedure time versus a pre-specified benchmark
时间窗: Perioperative
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Difference in case cost versus a pre-specified benchmark
时间窗: Perioperative
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
次要结局
- The Instrument exchanges time(Intra-operative)
- Total Resection time(Intra-operative)
- The Visibility score(Intra-operative)
- Adverse event(Within post-operative 30 days)
- The cost per case(Intra-operative)
- Staff usability scores(Intra-operative)
- Total procedure time(intra-operative)
研究者
Alex Qinyang Liu
Clinical Assistant Professor
Chinese University of Hong Kong