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

NCT07413120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

VasoClip®

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.

DEVICE

WeckClip®

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 & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV
  • Incheon St.Mary's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413120 on ClinicalTrials.gov