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Clinical Trials in the USA / NCT07035431
Recruiting Not applicable

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

NCT07035431 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Not applicable
Started
2026-09
Last updated
2026-08-21

Condition(s) studied

Anastomotic LeaksHartmanns Stump Leakage

Investigational drug(s) / intervention(s)

Endo-SPONGE

Endo-SPONGE: The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
University of California, Davis Medical Center Sacramento California Not Yet Recruiting
Orlando Regional Medical Center Orlando Florida Not Yet Recruiting
Cleveland Clinic Florida Weston Florida Not Yet Recruiting
Lahey Medical Center Burlington Massachusetts Not Yet Recruiting
Mount Sinai New York New York Recruiting
Cleveland Clinic Foundation Cleveland Ohio Not Yet Recruiting
Penn State Health Hershey Pennsylvania Recruiting
Thomas Jefferson University Hospital Philadelphia Pennsylvania Not Yet Recruiting
University of Washington Medical Center Seattle Washington Recruiting
Marshall University Medical Center Huntington West Virginia Recruiting

More Boston Scientific Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035431 on ClinicalTrials.gov ↗ ← All trials in the USA