CompletedPhase 3

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

South Korea40 participantsStarted 2020-05-07

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Ligation success rate

Timeframe: Intraoperative

Trial details

NCT IDNCT07413120

SponsorIncheon St.Mary's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

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