本研究为一项介入性、前瞻性、单中心研究,旨在评估一种新型射频及微波消融柔性双极装置(SpydrBlade Flex,CREO Medical,英国)用于表浅结直肠肿瘤患者结直肠ESD的安全性及有效性。
适应症:Colon Polyp、Colon Neoplasia
入组条件
纳入标准
- 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).
排除标准
- 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.
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。