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Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery

Study acronym: DRAIN Upper
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 0 → 2 primary endpoints
See other at-risk trials from Boston Scientific Corporation

Amendment history

2026-09-19
Trial status changed: Withheld → Not Yet Recruiting
Phase changed: not specified → not applicable
Primary endpoint(s) modified
Enrollment changed: None → 74
Sponsor changed: [Redacted] → Boston Scientific Corporation+19 characters
Was[Redacted]
NowBoston Scientific Corporation
Trial arms changed: 0 → 1
Interventions modified
2026-09-05
3 amendments v1-v3
3 re-verifications since 2026-07-21, no change to tracked fields
2026-07-14
Original filing
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
Trial Details
NCT Number NCT07711093
Lead Sponsor Boston Scientific Corporation
Conditions Anastomotic Leaks
Enrollment 74 participants
Start Date 2026-12
Primary Completion 2028-12 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-18