A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment
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
Esophageal diverticulum is a rare disease. Majority comes form the pharyngo-esophageal junction (70 % Zenker's Diverticulum), 10% are mediothoracic and 20% epiphrenic. Zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). For medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). Recently another technique involving magnet was described (3). Five patients were treated with success.
Considering the surgical risk, other techniques need to be evaluated. Using the Endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. If necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in Zenker's diverticulum treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic medio or epiphrenic diverticulum.
- •Age between 18-80 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.
- •Severe esophagitis
- •Gastro-duodenal ulcer
- •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;
- •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
- Dysphagia(one year from procedure)