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。