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

A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the 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.