Virtuoso Improving Anatomic Bladder Lesion Excision Trial
NCT ID: NCT06940648
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-04-17
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Virtuoso Surgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Teoh
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Countries
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Other Identifiers
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VES-173
Identifier Type: -
Identifier Source: org_study_id
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