A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Full Thickness Resection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence of all Adverse Device Effects
研究概览
简要总结
The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection.
Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesion untreatable with standard technique.
- •Age between 18-65 years;
- •Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
- •Must be able to understand and be willing to provide written informed consent;
- •Must live within 75 km of the treatment site;
排除标准
- •Achalasia and any other esophageal motility disorders (for upper GI lesion)
- •Severe esophagitis (for upper GI lesion)
- •Gastro-duodenal ulcer (for upper GI lesion)
- •Severe renal, hepatic, pulmonary disease or cancer;
- •GI stenosis or obstruction;
- •Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
- •Anticoagulant therapy;
- •Impending gastric surgery 60 days post intervention (Upper GI);
- •Currently participating in other study
结局指标
主要结局
Incidence of all Adverse Device Effects
时间窗: one year from procedure
Safety will be characterized by the incidence of all Adverse Device Effects
次要结局
- R0 resection(1 month after resection)