Kidney Cancers, Prostate Cancer (Adenocarcinoma), Urothelial Cancer
Conditions
Keywords
clip, randomized controlled trial, robotics, surgical clip
Brief 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.
Interventions
A novel polymer ligating clip featuring a proprietary Z-groove and elastic notch architecture. Designed to maximize the friction coefficient and interlocking with soft tissue during robotic urologic surgery. The clips are applied for vessel and tissue ligation during procedures such as radical prostatectomy or nephrectomy.
Conventional standard polymer ligating clip (Hem-o-lok system) used as an active comparator. Used for the same indications and surgical procedures as the experimental group to evaluate the comparative efficacy and safety.
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ligation success rate | Intraoperative | The rate at which clips are ligated as intended and maintained through the end of the procedure. |
Countries
South Korea