招募中 NCT06281080

新型腔内机械人系统用于膀胱肿瘤整块切除的首人体试验

膀胱癌/尿路上皮癌不适用

这是一项前瞻性单臂研究,旨在评估使用Zenith机械人系统进行经尿道膀胱肿瘤整块切除的可行性与安全性。

适应症:Bladder Cancer

入组条件

纳入标准

  • Age between 18 and 75 years
  • Body mass index \<35 kg/m2
  • Bladder tumour located \<3 cm in size; clinically non-muscle invasive bladder tumour
  • Clinically indicated for en-bloc resection.
  • Willingness to participate as demonstrated by giving informed consent

排除标准

  • Presence of endoscopic or imaging signs of detrusor muscle invasion
  • Contraindication to general anaesthesia / spinal anaesthesia
  • ASA \> 2 patients
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Un-corrected coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnant)

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。