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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
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A robotic assisted surgery for bladder lesion excision.
This is a single-center, non-randomized study to evaluate the use of the Virtuoso Endoscopy System (VES) to perform safe and effective bladder lesion excisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label, single arm | Experimental | This study will enroll subjects 22 years and older with bladder lesions that require removal and/or biopsy for diagnosis, who meet all the inclusion criteria and none of the exclusion criteria. The study purpose is to evaluate the use of the Virtuoso Endoscopy System (VES) to perform safe and effective bladder lesion excisions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. | Device | This study is to evaluate the use of the Virtuoso Endoscopy System (VES), which is a robotic enhanced system, to perform safe and effective bladder lesion excisions. |
| Measure | Description | Time Frame |
|---|---|---|
| Detrusor muscle presence in the pathologic specimen after VES procedure | Through study completion, an average of 30 days | |
| Adverse events | Intraoperative | |
| Adverse events | Through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion to standard cTURBT equipment | Intraoperative | |
| Rate of en bloc excision with VES | Intraoperative | |
| Complications (Clavien-Dindo) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Teoh | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong | Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276423 | Derived | Teoh JY, Bracco FM, Wong JH, Liu AQ, Yuen VW, Lai FP. A Novel Transurethral Robotic Platform for Performing En Bloc Resection of Bladder Tumour: Results from the First Phase of the VIABLE Trial. Eur Urol Oncol. 2026 Feb;9(1):111-115. doi: 10.1016/j.euo.2025.11.005. Epub 2025 Nov 22. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Intraoperative |
| Significant bladder perforation requiring intervention | Intraoperative |
| Urethral injury | Intraoperative |
| Transfusion rate | Intraoperative |
| Estimated blood loss | Intraoperative |
| Rate of patients where the obturator nerve complex was observed | Intraoperative |
| Mortality | Intraoperative |
| VES surgery procedural time | Intraoperative |
| Presence of clear, evaluable margins in excised specimen | Through study completion, an average of 30 days |
| Time of catheterization | Through study completion, an average of 30 days |
| Time of hospital stay | Through study completion, an average of 30 days |
| Complications (Clavien-Dindo) | Through study completion, an average of 30 days |
| Significant bladder perforation requiring intervention | Through study completion, an average of 30 days |
| Urethral injury | Through study completion, an average of 30 days |
| 30-day reoperation rate | Through study completion, an average of 30 days |
| 30-day hospital readmission rate | Through study completion, an average of 30 days |
| 30-day mortality | Through study completion, an average of 30 days |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |