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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea
Ligation success rate
The rate at which clips are ligated as intended and maintained through the end of the procedure.
Time frame: Intraoperative
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