Anastomotic LeaksDRAIN UpperNCT07711093
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
A study testing sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE in people with Anastomotic Leaks, run by Boston Scientific Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leaks
- What is being tested?
- sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University Medical Center
Dallas, Texas, 76246
Steven G Leeds, MD, 972-817-6050, Steven.leeds@bswhealth.org
About this 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
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.
Read the 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.
- Conditions
- Anastomotic Leaks
- Being tested
- sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
- Keywords
- Endoscopic Vacuum Therapy (EVT), Eso-Sponge, Sponge, Anastomotic Leaks, DRAIN Upper
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30-Days after study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeaksStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711093
- Sponsor's protocol ID
- E7211
- Acronym
- DRAIN Upper
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07711093
- Acronym / sponsor ID
- DRAIN Upper / E7211
- Conditions
- Anastomotic Leaks
- Keywords
- Endoscopic Vacuum Therapy (EVT), Eso-Sponge, Sponge, Anastomotic Leaks, DRAIN Upper
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eso-Sponge(TM) | Experimental | Device: sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGEPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed Type II anastomotic leaks in the esophagus or stomach
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGETreatment 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. | Device | Eso-Sponge(TM) |
Primary outcome
Serious Adverse Events
Time frame: Within 3-4 months
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.
Clinical Success
Time frame: 30-Days after study procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Anastomotic Leaks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE in people with Anastomotic Leaks, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelyne Ho, MPH, MBA (978-483-8856, evelyne.ho@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Within 3-4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.