A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 13
- 主要终点
- Serious Adverse Events
研究概览
简要总结
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.
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 grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery.
- •Subject is eligible for endoscopic intervention.
- •Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area.
- •Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity.
- •Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement.
- •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 colorectal indication.
- •Subject had colorectal surgery more than 60 days prior to the planned study procedure.
- •Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement.
- •Subject has known contraindication for EVT as per the 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
Endoscopic Vacuum Therapy (EVT) Device
干预措施: Endo-SPONGE (Device)
结局指标
主要结局
Serious Adverse Events
时间窗: Day 0 Study Procedure to end of study; up to 6 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: Day 0 Study Procedure to the last study device removal; up to 3 months
The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic or Hartmann's stump leak, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 3 months after the study procedure without the need for an additional endoscopic or surgical intervention.
次要结局
- Technical Success(Day 0 Study Procedure to the last study device exchange; up to 3 months)
- Closure Time(Day 0 Study Procedure to the last study device removal; up to 3 months)
- Rate of Reinterventions(From last study device removal to end of study; 3 months)
- Time to Additional Intervention(Day 0 Study Procedure to the last study device removal; up to 3 months)
- Leak Recurrence(From last study device removal to end of study; 3 months)
- Endo-SPONGE Exchanges(Day 0 Study Procedure to last study device removal; up to 3 months)
- Length of Hospitalization(Day 0 Study Procedure to end of study; up to 6 months)
- Mortality Rate(Day 0 Study Procedure to end of study; up to 6 months)