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Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
Sponsor: Boston Scientific Corporation
Summary
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.
Official title: A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Eso-SPONGE for the Treatment of Anastomotic Leaks in the Upper Gastrointestinal Tract
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2026-12
Completion Date
2029-04
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
Treatment of anastomotic leaks or perforations in the upper gastrointestinal tract by means of negative pressure including intraluminal or intracavitary therapy of paraoesophageal and mediastinal septic focus or localized abscesses that are endoscopically accessible within the range of the overtube length.
Locations (1)
Baylor University Medical Center
Dallas, Texas, United States