Boston Scientific Corporation
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.
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.
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 abl…
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.
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