Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Purpose
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
- Anastomotic Leaks
- Hartmanns Stump Leakage
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Endoscopic Vacuum Therapy (EVT) Device |
|
Recruiting Locations
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
Marshall University Medical Center
Huntington, West Virginia 25701
Huntington, West Virginia 25701
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation