Bladder NeoplasmNCT06940648
Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial
A study testing The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. in people with Bladder Neoplasm, run by Virtuoso Surgical, Inc. at 1 site in Hong Kong.
Trial summary
A robotic assisted surgery for bladder lesion excision. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Bladder Neoplasm
- What is being tested?
- The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Apr 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong
About this study
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.
- Conditions
- Bladder Neoplasm
- Being tested
- The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.
- Keywords
- Bladder Lesion, Resection, Excision, Bladder Tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detrusor muscle presence in the pathologic specimen after VES procedure
Measured: Through study completion, an average of 30 days
Adverse events
Measured: Intraoperative
Adverse events
Measured: Through study completion, an average of 30 days
Secondary outcomes (19)
Rate of conversion to standard cTURBT equipment
Measured: Intraoperative
Rate of en bloc excision with VES
Measured: Intraoperative
Complications (Clavien-Dindo)
Measured: Intraoperative
Significant bladder perforation requiring intervention
Measured: Intraoperative
Urethral injury
Measured: Intraoperative
Transfusion rate
Measured: Intraoperative
Estimated blood loss
Measured: Intraoperative
Rate of patients where the obturator nerve complex was observed
Measured: Intraoperative
Mortality
Measured: Intraoperative
VES surgery procedural time
Measured: Intraoperative
Presence of clear, evaluable margins in excised specimen
Measured: Through study completion, an average of 30 days
Time of catheterization
Measured: Through study completion, an average of 30 days
Time of hospital stay
Measured: Through study completion, an average of 30 days
Complications (Clavien-Dindo)
Measured: Through study completion, an average of 30 days
Significant bladder perforation requiring intervention
Measured: Through study completion, an average of 30 days
Urethral injury
Measured: Through study completion, an average of 30 days
30-day reoperation rate
Measured: Through study completion, an average of 30 days
30-day hospital readmission rate
Measured: Through study completion, an average of 30 days
30-day mortality
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start17 Apr 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virtuoso Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Jeremy Teoh, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940648
- Sponsor's protocol ID
- VES-173
- Status last verified
- Jun 2026
- First submitted
- 4 Apr 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial
- ClinicalTrials.gov ID
- NCT06940648
- Acronym / sponsor ID
- VES-173
- Conditions
- Bladder Neoplasm
- Keywords
- Bladder Lesion, Resection, Excision, Bladder Tumor
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virtuoso Surgical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label, single arm | Experimental | Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Open label, single arm |
Primary outcome
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
19 secondary outcomes
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
Time of hospital stay
Time frame: Through study completion, an average of 30 days
Complications (Clavien-Dindo)
Time frame: Through study completion, an average of 30 days
Significant bladder perforation requiring intervention
Time frame: Through study completion, an average of 30 days
Urethral injury
Time frame: Through study completion, an average of 30 days
30-day reoperation rate
Time frame: Through study completion, an average of 30 days
30-day hospital readmission rate
Time frame: Through study completion, an average of 30 days
30-day mortality
Time frame: Through study completion, an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 41276423Teoh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Teoh principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions. in people with Bladder Neoplasm, run by Virtuoso Surgical, Inc. at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detrusor muscle presence in the pathologic specimen after VES procedure (time frame: Through study completion, an average of 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.