Actively Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Led by Boston Scientific Corporation · Updated on 2026-05-07
66
Participants Needed
8
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed grade B anastomotic leak as per the ISGRC grading system after colorectal surgery
- Eligible for endoscopic intervention
- Transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area
- Anastomotic or Hartmann's stump leak located within an extraperitoneal cavity
- Pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement
- Willing and able to comply with study procedures and provide written informed consent
- Investigator decision that EVT is the most suitable treatment option
You will not qualify if you...
- Under 18 years of age
- Potentially vulnerable subjects, including pregnant women
- Previous EVT or similar interventions for the current colorectal indication
- Colorectal surgery performed more than 60 days before planned study procedure
- Presence of necrotic tissue requiring endoscopic debridement prior to Endo-SPONGE placement
- Known contraindication for EVT as per the Investigator's Brochure
- Currently enrolled in another investigational study that would interfere without sponsor approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Not Yet Recruiting
2
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Not Yet Recruiting
3
Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
5
Penn State Health
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
6
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
7
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
8
Marshall University Medical Center
Huntington, West Virginia, United States, 25701
Actively Recruiting
Research Team
S
Steve Fodem
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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