A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Eso-SPONGE for the Treatment of Anastomotic Leaks in the Upper Gastrointestinal Tract
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
研究概览
简要总结
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
详细描述
The study is a prospective multi-center, single -arm study with treatment of up to 74 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the Eso-Sponge and up to 4 months follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Type II anastomotic leaks in the esophagus or stomach
- •Type I: Leak requiring no change in treatment
- •Type II: Leak requiring intervention but not surgery
- •Type III: Leak requiring surgical intervention
- •Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length.
- •Subject is eligible for endoscopic intervention.
- •Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach.
- •Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.
- •Investigator decision that EVT is the most suitable treatment of the available treatment options.
排除标准
- •Subject is under 18 years of age.
- •Potentially vulnerable subject, including, but not limited to pregnant women.
- •Subject has undergone EVT or other similar interventions for the current leak.
- •Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure.
- •Subject has any necrotic tissue that would require endoscopic debridement prior to Eso-SPONGETM placement.
- •Subject has known contraindication for EVT as per the Investigator Brochure (IB)
- •Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
研究组 & 干预措施
Eso-Sponge(TM)
Patients who meet all the inclusion criteria and none of the exclusion criteria will have an Eso-Sponge(TM) placed for the treatment of anastomotic leaks in the upper gastrointestinal tract.
干预措施: sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE (Device)
结局指标
主要结局
Serious Adverse Events
时间窗: Within 3-4 months
The proportion of subjects with one or more study device or endoscopic or study procedure-related serious adverse events (SAEs) occurring up to 3 months after the last study device removal.
Clinical Success
时间窗: 30-Days after study procedure
The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic leak or perforation in the upper GIT, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 30 days after the study procedure without the need for an additional intervention. Note: Subjects without clinical success will be followed until the leak resolves or a permanent disease process stabilizes, up to 3 months post final sponge removal.
次要结局
未报告次要终点