VAC-Stent Registry

April 10, 2026 updated by: Markus M. Heiss

Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment

This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.

The VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.

The primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité
      • Berlin, Germany
        • Sana Klinikum Lichtenberg
      • Bochum, Germany
        • St. Josef-Hospital
      • Bonn, Germany
        • Johanniter Krankenhaus Bonn
      • Bremerhaven, Germany
        • Ameos Klinikum Am Bürgerpark
      • Celle, Germany
        • Allgemeines Krankenhaus Celle
      • Cologne, Germany, 51109
        • Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital
      • Dresden, Germany
        • Städtisches Klinikum Dresden
      • Düsseldorf, Germany
        • Uniklinik Düsseldorf
      • Hanover, Germany
        • KRH Klinikum Siloah
      • Osnabrück, Germany
        • Nils Stensen Kliniken, Marienhospital Osnabrück
      • Saarbrücken, Germany
        • Caritas Klinikum Saarbrücken - St. Theresia
      • Tübingen, Germany
        • Uniklinik Tübingen
      • Wiesbaden, Germany
        • Asklepios Paulinen Klinik Wiesbaden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • written informed consent
  • treatment with the VAC-Stent®

Exclusion Criteria:

- accommodation in an institution under court or administrative order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VAC-Stent® treatment
spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon
Device: VAC-Stent®
treatment with the VAC-Stent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful treatment of the leakage with the VAC-Stent®
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of morphological healing of the insufficiency
Time Frame: approximately 4 weeks after end of treatment
approximately 4 weeks after end of treatment
Number of Participants with complications
Time Frame: approximately 4 weeks after end of treatment
approximately 4 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Markus M. Heiss

Collaborators

University of Witten/Herdecke
VAC Stent GmbH
Möller Medical GmbH
MicroTech Europe GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC-Stent Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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