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Enrolling by invitation NCT06940648

Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial

No phase Interventional Bladder Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions..
Who it may be relevant to
Registry conditions: Bladder Neoplasm. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Detrusor muscle presence in the pathologic specimen after VES procedure [Time frame: Through study completion, an average of 30 days]
  • Adverse events [Time frame: Intraoperative]
  • Adverse events [Time frame: Through study completion, an average of 30 days]
Secondary outcome measures (12)
  • Rate of conversion to standard cTURBT equipment [Time frame: Intraoperative]
  • Rate of en bloc excision with VES [Time frame: Intraoperative]
  • Complications (Clavien-Dindo) [Time frame: Intraoperative]
  • Significant bladder perforation requiring intervention [Time frame: Intraoperative]
  • Urethral injury [Time frame: Intraoperative]
  • Transfusion rate [Time frame: Intraoperative]
  • Estimated blood loss [Time frame: Intraoperative]
  • Rate of patients where the obturator nerve complex was observed [Time frame: Intraoperative]
  • Mortality [Time frame: Intraoperative]
  • VES surgery procedural time [Time frame: Intraoperative]
  • Presence of clear, evaluable margins in excised specimen [Time frame: Through study completion, an average of 30 days]
  • Time of catheterization [Time frame: Through study completion, an average of 30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital, Chinese University of Hong Kong — Hong Kong

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. PMID 41276423

Identifiers

NCT: NCT06940648 · VES-173

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗