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NCT07035431NARecruiting

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

Boston Scientific Corporation

Start Date

7/1/2026

Completion Date

12/1/2028

Summary

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Endo-SPONGE

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Conditions

Anastomotic LeaksHartmanns Stump Leakage

Locations

Orlando Regional Medical Center

Orlando, Florida 32806

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Lahey Medical Center

Burlington, Massachusetts 01805

United States

Mount Sinai

New York, New York 10029

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Penn State Health

Hershey, Pennsylvania 17033

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

Marshall University Medical Center

Huntington, West Virginia 25701

United States