Virtuoso Improving Anatomic Bladder Lesion Excision Trial (VIABLE)

Virtuoso Surgical, Inc.

Status: Invitation-only

Conditions: Bladder Neoplasm

Treatments: Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06940648

VES-173

Details and patient eligibility

About

A robotic assisted surgery for bladder lesion excision.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open label, single arm

Experimental group

Description:

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.

Treatment:

Device: The study is to evaluate the use of the Virtuoso Endoscopy System to perform safe and effective bladder lesion excisions.