Virtuoso Improving Anatomic Bladder Lesion Excision Trial

NCT06940648 | Enrolling By Invitation

• 1 other identifier: VES-173
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A robotic assisted surgery for bladder lesion excision.

Conditions

Bladder Neoplasm

Keywords

Bladder Lesion; Resection; Excision; Bladder Tumor

Outcome Measures

Primary Outcomes (3)

• Detrusor muscle presence in the pathologic specimen after VES procedure

  Through study completion, an average of 30 days

• Adverse events

  Intraoperative

• Adverse events

  Through study completion, an average of 30 days

Secondary Outcomes (19)

• 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

Study Arms (1)

Open label, single arm

EXPERIMENTAL

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.

Interventions

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

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.

Open label, single arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virtuoso Surgical, Inc.: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 41276423 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeremy Teoh

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 23, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

HK (1)