Clinical trial · Interventional
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancers | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VasoClip® | Device | — | UNRESOLVED |
| WeckClip® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VasoClip® Group
- description
- 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.
- interventionNames
- Device: VasoClip®
- type
- ACTIVE_COMPARATOR
- label
- WeckClip® Group
- description
- 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.
- interventionNames
- Device: WeckClip®
Primary outcomes (1)
- measure
- Ligation success rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available