Endoscopic Treatment of Intestinal Fistulas and Perforations
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
详细描述
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastrointestinal fistula and perforation
- •Ability to undergo general anesthesia
- •Ability to give informed consent
排除标准
- •Contraindicated for esophagogastroduodenoscopy (EGD)
- •Contraindicated for colonoscopy
- •Presence of esophageal stricture
- •Altered gastric anatomy
- •Intraabdominal abscess or severe inflammation
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 6 months
elective endoscopy to evaluate tissue closure
次要结局
未报告次要终点