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Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery (DRAIN Upper)

2026年10月16日 更新者：Boston Scientific Corporation

A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Eso-SPONGE for the Treatment of Anastomotic Leaks in the Upper Gastrointestinal Tract

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

74

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Texas
      • Dallas、Texas、美国、76246

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

  1. 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

  2. Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length.

  3. Subject is eligible for endoscopic intervention.

  4. Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach.

  5. 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.

  6. Investigator decision that EVT is the most suitable treatment of the available treatment options.

Exclusion Criteria:

  1. Subject is under 18 years of age.
  2. Potentially vulnerable subject, including, but not limited to pregnant women.
  3. Subject has undergone EVT or other similar interventions for the current leak.
  4. Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure.
  5. Subject has any necrotic tissue that would require endoscopic debridement prior to Eso-SPONGETM placement.
  6. Subject has known contraindication for EVT as per the Investigator Brochure (IB)
  7. Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE

Treatment of anastomotic leaks or perforations in the upper gastrointestinal tract by means of negative pressure including intraluminal or intracavitary therapy of paraoesophageal and mediastinal septic focus or localized abscesses that are endoscopically accessible within the range of the overtube length.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Serious Adverse Events
大体时间：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.
Within 3-4 months
Clinical Success
大体时间：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.
30-Days after study procedure

其他结果措施

结果测量
措施说明
大体时间
Technical Success
大体时间：30-Days after study procedure

Defined as the ability to deploy the Eso-SPONGE in the intended position. This will be calculated for each study procedure and Eso-SPONGE Exchange.
30-Days after study procedure
Closure Time
大体时间：30-days after study procedure

Time to anastomotic leak closure from the surgery that led to the leak.
30-days after study procedure
Closure Time
大体时间：Through end of study, up to 4 months

Time to leak closure from the initial study procedure.
Through end of study, up to 4 months
Rate of Reinterventions
大体时间：Through study completion, an average of 3 to 4 months

Rate of Reinterventions after closure of the anastomotic leak.
Through study completion, an average of 3 to 4 months
Time to Additional Intervention
大体时间：30-days after study procedure

Time to additional intervention, if Eso-SPONGETM treatment is insufficient.
30-days after study procedure
Leak Recurrence
大体时间：Through study completion, an average of 3 to 4 months

Anastomotic leak recurrence within 3-months following completion of Eso-SPONGETM therapy.
Through study completion, an average of 3 to 4 months
Eso-SPONGE Exchanges
大体时间：30-days after study procedure

Number of Eso-SPONGETM exchanges needed to reach clinical success.
30-days after study procedure
Length of Hospitalization
大体时间：30 days after study procedure

Length of Hospitalization during EVT treatment.
30 days after study procedure
Mortality Rate
大体时间：Through study completion, an average of 3 to 4 months

Mortality rate through 3-month follow-up.
Through study completion, an average of 3 to 4 months
Unplanned Hospital Re-admissions
大体时间：Through study completion, an average of 3 to 4 months

Unplanned hospital re-admission related to the leak within 90 days of initial discharge.
Through study completion, an average of 3 to 4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boston Scientific Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年4月1日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年10月19日

上次提交的符合 QC 标准的更新

2026年10月16日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • E7211

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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