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

ArmDescriptionAssigned Intervention
Experimental
Endoscopic Vacuum Therapy (EVT) Device
  • Device: Endo-SPONGE
    The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.

Recruiting Locations

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Adam Templeton, MD
206-598-4377
ATempleton@medicine.washington.edu

Marshall University Medical Center
Huntington, West Virginia 25701
Contact:
Wesam Frandah, MD
304-691-1830
frandah@marshall.edu

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Steve Fodem
651-246-3094
Steve.Fodem@bsci.com