sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Serious Adverse Events — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Baylor University Medical Center
Dallas
Texas
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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