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

NCT07413120 | Completed Phase 3 DMC

• 1 other identifier: OC20DNST0054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer (Adenocarcinoma); Kidney Cancers; Urothelial Cancer

Keywords

clip; randomized controlled trial; robotics; surgical clip

Outcome Measures

Primary Outcomes (1)

• Ligation success rate

  The rate at which clips are ligated as intended and maintained through the end of the procedure.

  Intraoperative

Study Arms (2)

VasoClip® Group

EXPERIMENTAL

Participants undergoing robotic urologic surgery using the VasoClip®, a novel polymer ligating clip featuring a Z-groove and elastic notch designed to improve mechanical grip and prevent slippage.

Device: VasoClip®

WeckClip® Group

ACTIVE COMPARATOR

Participants undergoing robotic urologic surgery using the WeckClip® (Hem-o-lok®), a conventional standard polymer ligating clip used as the control for comparing efficacy and safety.

Device: WeckClip®

Interventions

VasoClip® DEVICE

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.

VasoClip® Group

WeckClip® DEVICE

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.

WeckClip® Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: May 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)