Clinical trial · Interventional
Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial
NCT06940648CI-TRIAL-00116187enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
A robotic assisted surgery for bladder lesion excision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Neoplasm | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open label, single arm
- description
- 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.
- interventionNames
- Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.
Primary outcomes (3)
- measure
- Detrusor muscle presence in the pathologic specimen after VES procedure
- timeFrame
- Through study completion, an average of 30 days
- measure
- Adverse events
- timeFrame
- Intraoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject is 22 years or older. 2. The subject is eligible and fit for transurethral bladder lesion removal and/or biopsy and has an appropriate indication to go through this surgery. 3. The subject is willing and able to provide written informed consent and comply with the study protocol. 4. The subject can undergo general anesthesia per anesthesiologist assessment. 5. The subject's planned aggregated bladder lesion(s) excision specimens are smaller than 3 cm. Exclusion Criteria: 1. The subject has acute untreated urinary tract infection or urosepsis. 2. The subject has a documented nickel allergy or nickel sensitivity. 3. The subject is confirmed to be or suspected to be pregnant. 4. The subject is receiving anticoagulants and is unable or not willing to cease the medication for the investigational procedure. 5. The subject belongs to a vulnerable group (prisoner, etc.) 6. The subject has a urethral abnormality, implant, or previous surgery which would conflict with the procedure. 7. The subject has undergone a transurethral bladder resection procedure in the past 6 months. 8. The subject has a history of radiation treatment within the pelvis. 9. Bladder tumor base maximal dimension is greater than 3 cm. 10. Bladder tumor detected during intravesical therapy. 11. Previous histological diagnosis different than non-muscle invasive bladder cancer. 12. Presence or prior history of upper urinary tract malignancy. 13. Eastern Cooperative Oncology Group performance status greater than or equal to 3. 14. American Society of Anesthesiologists physical status classification of IV or above. 15. History of bleeding disorder, coagulation abnormality, or use of anticoagulants. 16. The presence of other active malignancy. 17. Life expectancy \<1 yr.
References
Publications (1)
- DERIVEDTeoh 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. PMID 41276423