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Enrolling by invitationNCT06940648Updated Jun 29, 2026

Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial

An interventional study of The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. in Bladder Neoplasm, sponsored by Virtuoso Surgical, Inc.. Enrolling by invitation at 1 site in Hong Kong. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Virtuoso Surgical, Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

A robotic assisted surgery for bladder lesion excision.

Read the 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.

02

Conditions studied

  • Bladder Neoplasm

Keywords

  • Bladder Lesion
  • Resection
  • Excision
  • Bladder Tumor
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

This is the only study on the registry with Virtuoso Surgical, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 planned aggregated bladder lesion(s) excision specimens are smaller than 3 cm.

Exclusion criteria

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 a urethral abnormality, implant, or previous surgery which would conflict with the procedure.
  7. The subject has undergone a transurethral bladder resection procedure in the past 6 months.
  8. The subject has a history of radiation treatment within the pelvis.
  9. Bladder tumor base maximal dimension is greater than 3 cm.
  10. Bladder tumor detected during intravesical therapy.
  11. Previous histological diagnosis different than non-muscle invasive bladder cancer.
  12. Presence or prior history of upper urinary tract malignancy.
  13. Eastern Cooperative Oncology Group performance status greater than or equal to 3.
  14. American Society of Anesthesiologists physical status classification of IV or above.
  15. History of bleeding disorder, coagulation abnormality, or use of anticoagulants.
  16. The presence of other active malignancy.
  17. Life expectancy \<1 yr.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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.

Interventions

  • DeviceThe 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.

06

What researchers measure

Primary outcomes

  1. Detrusor muscle presence in the pathologic specimen after VES procedure

    Time frame: Through study completion, an average of 30 days

  2. Adverse events

    Time frame: Intraoperative

  3. Adverse events

    Time frame: Through study completion, an average of 30 days

Secondary outcomes

  1. Rate of conversion to standard cTURBT equipment

    Time frame: Intraoperative

  2. Rate of en bloc excision with VES

    Time frame: Intraoperative

  3. Complications (Clavien-Dindo)

    Time frame: Intraoperative

  4. Significant bladder perforation requiring intervention

    Time frame: Intraoperative

  5. Urethral injury

    Time frame: Intraoperative

  6. Transfusion rate

    Time frame: Intraoperative

  7. Estimated blood loss

    Time frame: Intraoperative

  8. Rate of patients where the obturator nerve complex was observed

    Time frame: Intraoperative

  9. Mortality

    Time frame: Intraoperative

  10. VES surgery procedural time

    Time frame: Intraoperative

  11. Presence of clear, evaluable margins in excised specimen

    Time frame: Through study completion, an average of 30 days

  12. Time of catheterization

    Time frame: Through study completion, an average of 30 days

  13. Time of hospital stay

    Time frame: Through study completion, an average of 30 days

  14. Complications (Clavien-Dindo)

    Time frame: Through study completion, an average of 30 days

  15. Significant bladder perforation requiring intervention

    Time frame: Through study completion, an average of 30 days

  16. Urethral injury

    Time frame: Through study completion, an average of 30 days

  17. 30-day reoperation rate

    Time frame: Through study completion, an average of 30 days

  18. 30-day hospital readmission rate

    Time frame: Through study completion, an average of 30 days

  19. 30-day mortality

    Time frame: Through study completion, an average of 30 days

07

Study locations

1 site
  • Prince of Wales Hospital, Chinese University of Hong Kong
    Hong Kong, Hong Kong, Hong Kong
08

References and documents

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. PubMed 41276423 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06940648
Lead sponsor
Virtuoso Surgical, Inc.
Collaborators
Chinese University of Hong Kong
Responsible party
Sponsor
First posted
Apr 23, 2025
Start date
Apr 17, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 29, 2026

Study contacts

Jeremy Teoh
principal investigator · Chinese University of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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