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NCT06940648 | NOT YET RECRUITING | Bladder Neoplasm

Virtuoso Improving Anatomic Bladder Lesion Excision Trial
Sponsor:

Virtuoso Surgical, Inc.

Brief Summary:

A robotic assisted surgery for bladder lesion excision.

Condition or disease

Bladder Neoplasm

Intervention/treatment

The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Virtuoso Improving Anatomic Bladder Lesion Excision Trial
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 aggregate bladder lesion(s) size is 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 bladder dome or diverticular lesions that are at an increased risk for perforation of the bladder.
  • 7. The subject's lesion(s) involve a ureteral orifice(s) necessitating additional endoscopic management and stenting.
  • 8. The subject has a urethral abnormality, implant, or previous surgery which would conflict with the procedure.
  • 9. The subject has undergone a transurethral bladder resection procedure in the past 6 months.
  • 10. The subject has a history of radiation treatment within the pelvis.
  • 11. Bladder tumor base maximal dimension is greater than 3 cm.
  • 12. Bladder tumor detected during intravesical therapy.
  • 13. Previous histological diagnosis different than non-muscle invasive bladder cancer.
  • 14. Presence or prior history of upper urinary tract malignancy.
  • 15. Eastern Cooperative Oncology Group performance status greater than or equal to 3.
  • 16. American Society of Anesthesiologists physical status classification of III or above.
  • 17. History of bleeding disorder, coagulation abnormality, or use of anticoagulants.
  • 18. The presence of other active malignancy.
  • 19. Life expectancy \<1 yr.
Virtuoso Improving Anatomic Bladder Lesion Excision Trial

Location Details

NCT06940648

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Hong Kong,

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong,