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

Study acronym: DRAIN Lower
StatusRecruiting
PhaseNot applicable
Started2026-10
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
Study Status, Contacts/Locations v16
Start date2026-07→2026-09
Study sites9→10
2026-07-23
Study Status v15
Re-verified, no change to tracked fields
2026-06-17
Study Status, Contacts/Locations v14
Start date2026-05→2026-07
Study sites8→9
2026-05-06
Study Status, Contacts/Locations v13
Start date2026-04→2026-05
Study sites6→8
2026-04-07
Study Status, Contacts/Locations v12
Start date2026-03→2026-04
Study sites6 entries, revised
OhioCleveland StateClinic University Medical CenterFlorida
Show 11 earlier versions
2026-03-02
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 6 sites
2026-02-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start date2026-01→2026-03
Study sites8→6
2026-01-08
Study Status v9
Re-verified, no change to tracked fields
2025-12-16
Study Status, Contacts/Locations v8
Start date2025-11→2026-01
Study sites5→8
2025-11-06
Study Status v7
Re-verified, no change to tracked fields
2025-10-14
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 5 sites
2025-09-26
Study Status v5
Start date2025-12→2025-11
2025-08-26
Study Status, Contacts/Locations v4
Study sites6→5
2025-08-11
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 6 sites
2025-07-28
Study Status v2
Re-verified, no change to tracked fields
2025-07-16
Study Status, Contacts/Locations v1
Study sites7→6
2025-06-16
Original filing
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.
Trial Details
NCT Number NCT07035431
Lead Sponsor Boston Scientific Corporation
Conditions Anastomotic Leaks, Hartmanns Stump Leakage
Enrollment 66 participants
Start Date 2026-10
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-24