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

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

• 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.

Exclusion criteria

• 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.