A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area
Boston Scientific Corporation
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
- Age range
- 18+ years
- Sex
- All
- 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 abl…
Interventions
- DeviceEndo-SPONGE
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Locations (8)
- Orlando Regional Medical CenterOrlando, Florida
- Cleveland Clinic FloridaWeston, Florida
- Mount SinaiNew York, New York
- Cleveland Clinic FoundationCleveland, Ohio
- Penn State HealthHershey, Pennsylvania
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania