Overview
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.
Eligibility
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.
