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

Recruiting N/A Interventional Study
Anastomotic Leaks Hartmanns Stump Leakage
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
Boston Scientific Corporation · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 surg…
Contacts

Steve Fodem

651-246-3094

Steve.Fodem@bsci.com

CONTACT