招募中 NCT06281080

新型腔內機械人系統用於膀胱腫瘤整塊切除的首人體試驗

膀胱癌/泌尿道上皮癌不適用

這是一項前瞻性單臂研究,旨在評估使用Zenith機械人系統進行經尿道膀胱腫瘤整塊切除的可行性與安全性。

適應症:Bladder Cancer

收案條件

納入條件

  • 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

排除條件

  • 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)

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。