Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial

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.

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.