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

A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Eso-SPONGE for the Treatment of Anastomotic Leaks in the Upper Gastrointestinal Tract

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anastomotic Leaks
• Intervention / Treatment: Device: sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE

Detailed Description

The study is a prospective multi-center, single -arm study with treatment of up to 74 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the Eso-Sponge and up to 4 months follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyne Ho, MPH, MBA; Phone Number: 978-483-8856; Email: evelyne.ho@bsci.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 76246
      • Baylor University Medical Center
      • Contact: Steven G Leeds, MD; Phone Number: 972-817-6050; Email: Steven.leeds@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. 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

2. Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length.

3. Subject is eligible for endoscopic intervention.

4. Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach.

5. 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.

6. Investigator decision that EVT is the most suitable treatment of the available treatment options.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Defined as the ability to deploy the Eso-SPONGE in the intended position. This will be calculated for each study procedure and Eso-SPONGE Exchange.	30-Days after study procedure
Closure Time	Time to anastomotic leak closure from the surgery that led to the leak.	30-days after study procedure
Closure Time	Time to leak closure from the initial study procedure.	Through end of study, up to 4 months
Rate of Reinterventions	Rate of Reinterventions after closure of the anastomotic leak.	Through study completion, an average of 3 to 4 months
Time to Additional Intervention	Time to additional intervention, if Eso-SPONGETM treatment is insufficient.	30-days after study procedure
Leak Recurrence	Anastomotic leak recurrence within 3-months following completion of Eso-SPONGETM therapy.	Through study completion, an average of 3 to 4 months
Eso-SPONGE Exchanges	Number of Eso-SPONGETM exchanges needed to reach clinical success.	30-days after study procedure
Length of Hospitalization	Length of Hospitalization during EVT treatment.	30 days after study procedure
Mortality Rate	Mortality rate through 3-month follow-up.	Through study completion, an average of 3 to 4 months
Unplanned Hospital Re-admissions	Unplanned hospital re-admission related to the leak within 90 days of initial discharge.	Through study completion, an average of 3 to 4 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): October 19, 2026
• Last Update Submitted That Met QC Criteria: October 16, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Sponge; Anastomotic Leaks; Endoscopic Vacuum Therapy (EVT); Eso-Sponge; DRAIN Upper
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anastomotic Leak
• Other Study ID Numbers: E7211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes