Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ENROLLING_BY_INVITATION

Virtuoso Improving Anatomic Bladder Lesion Excision Trial

Lead Sponsor:

Virtuoso Surgical, Inc.

Collaborating Sponsors:

Chinese University of Hong Kong

Conditions:

Bladder Neoplasm

Eligibility:

All Genders

22+ years

Phase:

NA

Brief Summary

A robotic assisted surgery for bladder lesion excision.

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.

Eligibility Criteria

Inclusion

  • 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 aggregate bladder lesion(s) size is smaller than 3 cm.

Exclusion

  • 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 bladder dome or diverticular lesions that are at an increased risk for perforation of the bladder.
  • The subject's lesion(s) involve a ureteral orifice(s) necessitating additional endoscopic management and stenting.
  • 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 III or above.
  • History of bleeding disorder, coagulation abnormality, or use of anticoagulants.
  • The presence of other active malignancy.
  • Life expectancy \<1 yr.

Key Trial Info

Start Date :

April 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06940648

Start Date

April 17 2025

End Date

January 1 2026

Last Update

May 6 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong