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)
Serious Adverse Events — Day 0 Study Procedure to end of study; up to 6 months The proportion of subjects with one or more study device or endoscopic or study procedure-related Serious Adverse Events (SAEs) occurring up to 3 months after the last study device removal.
Clinical Success — Day 0 Study Procedure to the last study device removal; up to 3 months The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic or Hartmann's stump leak, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 3 months after the study procedure without the need for an additional endoscopic or surgical intervention.
Trial sites (10)
Facility
City
Region
Status
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
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.
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