Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial (VIABLE)

A robotic assisted surgery for bladder lesion excision.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bladder Neoplasm
• Intervention / Treatment: Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong
    • Hong Kong, Hong Kong, Hong Kong
      • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label, single arm; 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.	Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.; This study is to evaluate the use of the Virtuoso Endoscopy System (VES), which is a robotic enhanced system, to perform safe and effective bladder lesion excisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Through study completion, an average of 30 days
Detrusor muscle presence in the pathologic specimen after VES procedure	Through study completion, an average of 30 days
Adverse events	Intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Estimated blood loss	Intraoperative
Rate of conversion to standard cTURBT equipment	Intraoperative
Rate of en bloc or modified en bloc lesion excision with VES	Intraoperative
Complications (Clavien-Dindo)	Intraoperative
Significant bladder perforation requiring intervention	Intraoperative
Urethral injury	Intraoperative
Transfusion rate	Intraoperative
Rate of patients where the obturator nerve complex was observed	Intraoperative
Mortality	Intraoperative
VES surgery procedural time	Intraoperative
Presence of clear, evaluable margins in excised specimen	Through study completion, an average of 30 days
Time of catheterization	Through study completion, an average of 30 days
Time of hospital stay	Through study completion, an average of 30 days
Complications (Clavien-Dindo)	Through study completion, an average of 30 days
Significant bladder perforation requiring intervention	Through study completion, an average of 30 days
Urethral injury	Through study completion, an average of 30 days
30-day reoperation rate	Through study completion, an average of 30 days
30-day hospital readmission rate	Through study completion, an average of 30 days
30-day mortality	Through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: Virtuoso Surgical, Inc.
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Jeremy Teoh, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Teoh 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bladder Tumor; Resection; Excision; Bladder Lesion
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: VES-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes