Clinical trial NCT06940648: Virtuoso Improving Anatomic Bladder Lesion Excision Trial
Official title: Virtuoso Improving Anatomic Bladder Lesion Excision Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bladder Neoplasm
Keywords: Bladder Lesion
Resection
Excision
Bladder Tumor
Lead sponsor: Virtuoso Surgical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Chinese University of Hong Kong
First posted: 2025-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detrusor muscle presence in the pathologic specimen after VES procedure
timeFrame: Through study completion, an average of 30 days
measure: Adverse events
timeFrame: Intraoperative
measure: Adverse events
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Rate of conversion to standard cTURBT equipment
timeFrame: Intraoperative
measure: Rate of en bloc or modified en bloc lesion excision with VES
timeFrame: Intraoperative
measure: Complications (Clavien-Dindo)
timeFrame: Intraoperative
measure: Significant bladder perforation requiring intervention
timeFrame: Intraoperative
measure: Urethral injury
timeFrame: Intraoperative
measure: Transfusion rate
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Rate of patients where the obturator nerve complex was observed
timeFrame: Intraoperative
measure: Mortality
timeFrame: Intraoperative
measure: VES surgery procedural time
timeFrame: Intraoperative
measure: Presence of clear, evaluable margins in excised specimen
timeFrame: Through study completion, an average of 30 days
measure: Time of catheterization
timeFrame: Through study completion, an average of 30 days
measure: Time of hospital stay
timeFrame: Through study completion, an average of 30 days
measure: Complications (Clavien-Dindo)
timeFrame: Through study completion, an average of 30 days
measure: Significant bladder perforation requiring intervention
timeFrame: Through study completion, an average of 30 days
measure: Urethral injury
timeFrame: Through study completion, an average of 30 days
measure: 30-day reoperation rate
timeFrame: Through study completion, an average of 30 days
measure: 30-day hospital readmission rate
timeFrame: Through study completion, an average of 30 days
measure: 30-day mortality
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Jeremy Teoh
role: PRINCIPAL_INVESTIGATOR
References: