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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Boston Scientific Corporation
Study ID
NCT07711093
Status
Not Yet Recruiting

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Conditions

  • Anastomotic Leaks

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Dec 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Eso-Sponge(TM)
    Patients who meet all the inclusion criteria and none of the exclusion criteria will have an Eso-Sponge(TM) placed for the treatment of anastomotic leaks in the upper gastrointestinal tract.

Primary Outcome Measure

Serious Adverse Events [ Time Frame: Within 3-4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas76246
Steven G Leeds, MD
[email protected]
972-817-6050

Find similar trials in Dallas, TX

By research site
Baylor University Medical Center· Dallas, TX

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