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

Boston Scientific

Status

Not yet enrolling

Conditions

Hartmanns Stump Leakage

Anastomotic Leaks

Treatments

Device: Endo-SPONGE

Study type

Interventional

Funder types

Industry

Identifiers

NCT07035431

E7212

Details and patient eligibility

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.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.