即將開始 NCT06715332

使用新型雙極剪刀於結直腸內窺鏡黏膜下剝離術的前瞻性研究

大腸直腸癌不適用

本研究為一項介入性、前瞻性、單中心研究,旨在評估一種新型射頻及微波消融柔性雙極裝置(SpydrBlade Flex,CREO Medical,英國)用於表淺結直腸腫瘤患者結直腸ESD的安全性及有效性。

適應症:Colon Polyp、Colon Neoplasia

收案條件

納入條件

  • Adult patient (age ≥18 and ≤80 years-old)
  • Capability of understanding and complying with the study requirements, including signing the informed consent form.
  • Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).

排除條件

  • Patients unable or unwilling to provide consent.
  • Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
  • Patients with lesions involving the appendiceal orifice or ileocaecal valve.
  • Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
  • Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
  • Pregnant women or those planning pregnancy or breastfeeding women.
  • Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.

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。