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

Launched by BOSTON SCIENTIFIC CORPORATION · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Endo-SPONGE, which uses a special sponge placed through a scope to help heal leaks that can happen after surgery in the lower part of the bowel. These leaks, known as anastomotic or Hartmann’s stump leakages, can occur after colorectal surgery and need careful treatment to prevent complications. The study aims to see how safe and effective this sponge treatment is for patients with these types of leaks.

People who may be eligible for this study are adults aged 65 to 74 who have a confirmed leak of a certain size (at least 2 cm) in the lower pelvic area after colorectal surgery. They must have a temporary opening (ostomy) to divert stool either already in place or created before starting the treatment. Participants need to be able to understand the study and agree to follow all procedures. Those who have had this type of treatment before, have very damaged tissue requiring other procedures first, or are pregnant will not be eligible. If they join, patients can expect to undergo the sponge treatment through an endoscope (a thin, flexible tube with a camera) and will be carefully monitored to see how well the sponge helps the leak heal. This study is not yet recruiting patients but will take place at multiple centers.

Gender

ALL

Eligibility criteria

• 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.