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

This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.

Inclusion Criteria: * Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal 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 colorectal surgery in the lower pelvic area. * Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity. * Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement. * 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 colorectal indication. * Subject had colorectal surgery more than 60 days prior to the planned study procedure. * Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement. * Subject has known contraindication for EVT as per the IB. * Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.