Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Endo-SPONGE
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov