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New Stent-Suction combo shows promise for sealing gut leaks

NCT ID NCT04884334

Disease control Sponsor: Markus M. Heiss 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a device called the VAC-Stent, which combines a covered metal stent with negative pressure (suction) to seal leaks in the esophagus or colon. Researchers collected data from 110 patients to see if the device safely and effectively closed the leaks. The goal was to confirm the device works and track any complications.

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

110 people

The number who actually took part.

Started

Jul 2020

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon

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: * written informed consent * treatment with the VAC-Stent® Exclusion Criteria: \- accommodation in an institution under court or administrative order

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Conditions

The condition(s) this trial relates to.

Boerhaave syndrome Esophageal Perforation intestinal perforation

As listed by the trial registrant

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

Perforation of the colon Perforation of the oesophagus

Contacts and locations

Locations

  • Allgemeines Krankenhaus Celle

    Celle, Germany

  • Ameos Klinikum Am Bürgerpark

    Bremerhaven, Germany

  • Asklepios Paulinen Klinik Wiesbaden

    Wiesbaden, Germany

  • Caritas Klinikum Saarbrücken - St. Theresia

    Saarbrücken, Germany

  • Charité

    Berlin, Germany

  • Johanniter Krankenhaus Bonn

    Bonn, Germany

  • KRH Klinikum Siloah

    Hanover, Germany

  • Nils Stensen Kliniken, Marienhospital Osnabrück

    Osnabrück, Germany

  • Sana Klinikum Lichtenberg

    Berlin, Germany

  • St. Josef-Hospital

    Bochum, Germany

  • Städtisches Klinikum Dresden

    Dresden, Germany

  • Uniklinik Düsseldorf

    Düsseldorf, Germany

  • Uniklinik Tübingen

    Tübingen, Germany

  • Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital

    Cologne, 51109, Germany