Bladder Neoplasm
Conditions
Keywords
Bladder Lesion, Resection, Excision, Bladder Tumor
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.
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.
Sponsors
Virtuoso Surgical, Inc.
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | Intraoperative |
| Detrusor muscle presence in the pathologic specimen after VES procedure | Through study completion, an average of 30 days |
Secondary
| Measure | Time frame |
|---|---|
| VES surgery procedural time | Intraoperative |
| Presence of clear, evaluable margins in excised specimen | Through study completion, an average of 30 days |
| Time of catheterization | Through study completion, an average of 30 days |
| Time of hospital stay | Through study completion, an average of 30 days |
| 30-day reoperation rate | Through study completion, an average of 30 days |
| Rate of conversion to standard cTURBT equipment | Intraoperative |
| Rate of en bloc excision with VES | Intraoperative |
| Complications (Clavien-Dindo) | Intraoperative |
| Significant bladder perforation requiring intervention | Intraoperative |
| Urethral injury | Intraoperative |
| Transfusion rate | Intraoperative |
| Estimated blood loss | Intraoperative |
| Rate of patients where the obturator nerve complex was observed | Intraoperative |
| 30-day hospital readmission rate | Through study completion, an average of 30 days |
| Mortality | Intraoperative |
| 30-day mortality | Through study completion, an average of 30 days |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORJeremy Teoh
Chinese University of Hong Kong
Outcome results
None listed