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.

• sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE (Device): 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.

Primary outcomes

• 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.

Other outcomes

• Technical Success [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.
• Closure Time [30-days after study procedure]: Time to anastomotic leak closure from the surgery that led to the leak.
• Closure Time [Through end of study, up to 4 months]: Time to leak closure from the initial study procedure.
• Rate of Reinterventions [Through study completion, an average of 3 to 4 months]: Rate of Reinterventions after closure of the anastomotic leak.
• Time to Additional Intervention [30-days after study procedure]: Time to additional intervention, if Eso-SPONGETM treatment is insufficient.
• Leak Recurrence [Through study completion, an average of 3 to 4 months]: Anastomotic leak recurrence within 3-months following completion of Eso-SPONGETM therapy.
• Eso-SPONGE Exchanges [30-days after study procedure]: Number of Eso-SPONGETM exchanges needed to reach clinical success.
• Length of Hospitalization [30 days after study procedure]: Length of Hospitalization during EVT treatment.
• Mortality Rate [Through study completion, an average of 3 to 4 months]: Mortality rate through 3-month follow-up.
• Unplanned Hospital Re-admissions [Through study completion, an average of 3 to 4 months]: Unplanned hospital re-admission related to the leak within 90 days of initial discharge.

Sex: All, ages: 18 Years to any

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.