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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ligation success rate | The rate at which clips are ligated as intended and maintained through the end of the procedure. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |