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Vacuum therapy may stop deadly leaks after esophageal cancer surgery

NCT ID NCT06097078

Disease control Sponsor: Aesculap AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special vacuum device placed inside the esophagus right after cancer surgery to prevent dangerous leaks where the stomach is reconnected to the esophagus. About 44 adults having minimally invasive esophageal cancer surgery will receive this preventive treatment. The goal is to see if it lowers the rate of anastomotic leaks, a serious complication that can lead to infection or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Eso-SPONGE® device (endoluminal vacuum therapy)
What this could lead to
If it works, this could offer a way to prevent a serious complication after esophageal cancer surgery, potentially reducing infections and deaths.
What could go wrong
This is a small, early-stage study with only 44 participants and no comparison group, so results may not apply broadly. The device itself carries risks like discomfort or rare injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients undergoing a total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE® application to prevent anastomotic leakage (AL)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage * Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form * Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study. Exclusion Criteria: * Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE. * Multi-organ resection during the esophagectomy. * Emergent-urgent esophagectomy. * Coloplasty or small bowel plasty. * Necrotic tissue/gangrene. * Blood clotting disorder. * Bleeding esophageal varices. * Sponge placement required directly on major vessels. * Patients with known sensitivities or allergies to its components * Participation in any other clinical trial and use of any drug or experimental device, currently or in the 4 weeks prior to inclusion in the study. * Women who are pregnant, suspected of being pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak esophageal cancer Esophageal Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anastomotic leak Esophageal cancer Esophagus cancer

Contacts and locations

Locations

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.