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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).

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07413120
Enrollment
40
Registered
2026-02-17
Start date
2020-05-07
Completion date
2020-12-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancers, Prostate Cancer (Adenocarcinoma), Urothelial Cancer

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

DEVICEVasoClip®

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.

DEVICEWeckClip®

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

Incheon St.Mary's Hospital
Lead SponsorOTHER
Korea Health Industry Development Institute
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Ligation success rateIntraoperativeThe rate at which clips are ligated as intended and maintained through the end of the procedure.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026