Enrolling by invitation NCT06940648

Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial

Bladder / Urothelial CancerN/A

A robotic assisted surgery for bladder lesion excision.

Conditions: Bladder Neoplasm

Eligibility Criteria

Inclusion Criteria

  • The subject is 22 years or older.
  • The subject is eligible and fit for transurethral bladder lesion removal and/or biopsy and has an appropriate indication to go through this surgery.
  • The subject is willing and able to provide written informed consent and comply with the study protocol.
  • The subject can undergo general anesthesia per anesthesiologist assessment.
  • The subject's planned aggregated bladder lesion(s) excision specimens are smaller than 3 cm.

Exclusion Criteria

  • The subject has acute untreated urinary tract infection or urosepsis.
  • The subject has a documented nickel allergy or nickel sensitivity.
  • The subject is confirmed to be or suspected to be pregnant.
  • The subject is receiving anticoagulants and is unable or not willing to cease the medication for the investigational procedure.
  • The subject belongs to a vulnerable group (prisoner, etc.)
  • The subject has a urethral abnormality, implant, or previous surgery which would conflict with the procedure.
  • The subject has undergone a transurethral bladder resection procedure in the past 6 months.
  • The subject has a history of radiation treatment within the pelvis.
  • Bladder tumor base maximal dimension is greater than 3 cm.
  • Bladder tumor detected during intravesical therapy.
  • Previous histological diagnosis different than non-muscle invasive bladder cancer.
  • Presence or prior history of upper urinary tract malignancy.
  • Eastern Cooperative Oncology Group performance status greater than or equal to 3.
  • American Society of Anesthesiologists physical status classification of IV or above.
  • History of bleeding disorder, coagulation abnormality, or use of anticoagulants.
  • The presence of other active malignancy.
  • Life expectancy \<1 yr.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.