一种用于膀胱病灶切除的机械人辅助手术。
适应症：Bladder Neoplasm
入组条件
纳入标准
- 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.
排除标准
- 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.
- 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。