Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

Inclusion Criteria:

• Confirmed grade B anastomotic leak as per the ISGRC (International Study Group ofRectal Cancer) grading system after colorectal surgery.

• Subject is eligible for endoscopic intervention.

• Subject has a transmural defect of at least 2 cm in diameter following colorectalsurgery in the lower pelvic area.

• Subject has an anastomotic or Hartmann's stump leak located within anextraperitoneal cavity.

• Subject has pre-existing diverting ostomy or an ostomy created prior to the firstEndo-SPONGE placement.

• Subject understands the trial requirements and is willing and able to comply withthe study procedures, all protocol-required follow up evaluations and providewritten informed consent to participate in the study.

• Investigator decision that EVT is the most suitable treatment of the availabletreatment 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 colorectalindication.

• Subject had colorectal surgery more than 60 days prior to the planned studyprocedure.

• Subject has any necrotic tissue that would require endoscopic debridement prior toEndo-SPONGE placement.

• Subject has known contraindication for EVT as per the IB.

• Subject is currently enrolled in another investigational study that would directlyinterfere with the current study, without prior written approval from the sponsor.