The Clinical Trial to Evaluate the Efficacy and Safety of an Implantable Vascular Clip (Vaso Clip).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ligation success rate
研究概览
简要总结
This prospective, randomized, Phase III trial evaluates the efficacy and safety of VasoClip®, a novel polymer surgical clip with a Z-groove and an elastic notch, designed to enhance mechanical grip and prevent slippage. Forty patients undergoing robotic urologic surgery were randomized to receive either VasoClip® or the standard WeckClip®. The primary objective is to compare ligation success rates, assessed through a double-blinded review of surgical videos. This study aims to provide clinical evidence for the performance and safety of this structurally improved device in robot-assisted procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years or older.
- •Scheduled for robotic or laparoscopic urologic surgery where the use of polymer ligating clips is anticipated.
- •Voluntary informed consent.
排除标准
- •Clinically significant coagulation disorders (PT-INR > 1.2).
- •Severe vascular diseases (e.g., peripheral arterial occlusion, microvascular heart disease).
- •Comorbidities inducing excessive bleeding (e.g., active urinary tract infection, liver cirrhosis).
- •Conditions affecting blood cell or platelet production (e.g., leukemia).
- •Known coagulation factor deficiencies (e.g., hemophilia)
研究组 & 干预措施
VasoClip® Group
Participants undergoing robotic urologic surgery using the VasoClip®, a novel polymer ligating clip featuring a Z-groove and elastic notch designed to improve mechanical grip and prevent slippage.
干预措施: VasoClip® (Device)
WeckClip® Group
Participants undergoing robotic urologic surgery using the WeckClip® (Hem-o-lok®), a conventional standard polymer ligating clip used as the control for comparing efficacy and safety.
干预措施: WeckClip® (Device)
结局指标
主要结局
Ligation success rate
时间窗: Intraoperative
The rate at which clips are ligated as intended and maintained through the end of the procedure.
次要结局
未报告次要终点
研究者
JungJun Kim
Professor
Incheon St.Mary's Hospital