NCT07711093

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Dec 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

July 14, 2026

Last Update Submit

September 17, 2026

Conditions

Anastomotic Leaks

Keywords

Endoscopic Vacuum Therapy (EVT)Eso-SpongeSpongeAnastomotic LeaksDRAIN Upper

Outcome Measures

Primary Outcomes (2)

  • Serious Adverse Events

    The proportion of subjects with one or more study device or endoscopic or study procedure-related serious adverse events (SAEs) occurring up to 3 months after the last study device removal.

    Within 3-4 months

  • Clinical Success

    The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic leak or perforation in the upper GIT, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 30 days after the study procedure without the need for an additional intervention. Note: Subjects without clinical success will be followed until the leak resolves or a permanent disease process stabilizes, up to 3 months post final sponge removal.

    30-Days after study procedure

Other Outcomes (10)

  • Technical Success

    30-Days after study procedure

  • Closure Time

    30-days after study procedure

  • Closure Time

    Through end of study, up to 4 months

  • +7 more other outcomes

Study Arms (1)

Eso-Sponge(TM)

EXPERIMENTAL

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.

Device: sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE

Interventions

sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGEDEVICE

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.

Eso-Sponge(TM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Type II anastomotic leaks in the esophagus or stomach
  • Type I: Leak requiring no change in treatment
  • Type II: Leak requiring intervention but not surgery
  • Type III: Leak requiring surgical intervention
  • Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length.
  • Subject is eligible for endoscopic intervention.
  • Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach.
  • Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.
  • Investigator decision that EVT is the most suitable treatment of the available treatment options.

You may not qualify if:

  • Subject is under 18 years of age.
  • Potentially vulnerable subject, including, but not limited to pregnant women.
  • Subject has undergone EVT or other similar interventions for the current leak.
  • Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure.
  • Subject has any necrotic tissue that would require endoscopic debridement prior to Eso-SPONGETM placement.
  • Subject has known contraindication for EVT as per the Investigator Brochure (IB)
  • Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 76246, United States

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Evelyne Ho, MPH, MBA

CONTACT

978-483-8856evelyne.ho@bsci.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations

US(1)