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

Recruiting now · Not applicable

Conditions studied: Anastomotic Leaks, Hartmanns Stump Leakage

In brief

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.

Key facts

Study ID

NCT07035431

Run by

Boston Scientific Corporation

People needed

66

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mount Sinai — New York, New York, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• Marshall University Medical Center — Huntington, West Virginia, United States (enrolling)
• Orlando Regional Medical Center — Orlando, Florida, United States
• Penn State Health — Hershey, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Lahey Medical Center — Burlington, Massachusetts, United States

Full record on ClinicalTrials.gov

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