Efficacy and Safety of VasoClip® vs. WeckClip® for Robotic Urologic Surgery

The Clinical Trial to Evaluate the Efficacy and Safety of an Implantable Vascular Clip (Vaso Clip).

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)