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OpenTrials
Completed

NCT Number: NCT07413120

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

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.

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Cancers Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Incheon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Ligation success rate

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

The Clinical Trial to Evaluate the Efficacy and Safety of an Implantable Vascular Clip (Vaso Clip).

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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