Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.
New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.
The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submucosal tumor (< 4 cm)
- •Mucosal tumor (T1) in patients unsuitable for surgery
排除标准
- •Endoscopic ultrasound (EUS) or CT signs of metastasis
- •Insufficient access to tumor