Clinical Trial

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

Study acronym: DRAIN Lower
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2025-06-16; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2026-02-17
Trial Details
NCT Number NCT07035431
Lead Sponsor Boston Scientific Corporation
Conditions Anastomotic Leaks, Hartmanns Stump Leakage
Enrollment 66 participants
Start Date 2026-07
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24