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Completed

NCT Number: NCT04884334

VAC-Stent Registry

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.

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Key information

Conditions

Perforation of the Oesophagus Digestive System Diseases Esophageal Diseases Esophageal Perforation Gastrointestinal Diseases Perforation of the Colon Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • accommodation in an institution under court or administrative order

Treatment and study plan

VAC-Stent®

Device

treatment with the VAC-Stent®

Primary outcomes

  1. Successful treatment of the leakage with the VAC-Stent®

    Time frame: up to 6 months

Secondary outcomes

  1. Rate of morphological healing of the insufficiency

    Time frame: approximately 4 weeks after end of treatment

  2. Number of Participants with complications

    Time frame: approximately 4 weeks after end of treatment

Sponsors and collaborators

Lead sponsor

Markus M. Heiss

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 13, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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