VAC-Stent Registry

Last updated: December 9, 2024
Sponsor: Markus M. Heiss
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

VAC-Stent®

Clinical Study ID

NCT04884334
VAC-Stent Registry
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • written informed consent

  • treatment with the VAC-Stent®

Exclusion

Exclusion Criteria:

  • accommodation in an institution under court or administrative order

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: VAC-Stent®
Phase:
Study Start date:
July 01, 2020
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Charité

    Berlin,
    Germany

    Active - Recruiting

  • Sana Klinikum Lichtenberg

    Berlin,
    Germany

    Active - Recruiting

  • St. Josef-Hospital

    Bochum,
    Germany

    Active - Recruiting

  • Johanniter Krankenhaus Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Ameos Klinikum Am Bürgerpark

    Bremerhaven,
    Germany

    Active - Recruiting

  • Allgemeines Krankenhaus Celle

    Celle,
    Germany

    Active - Recruiting

  • Städtisches Klinikum Dresden

    Dresden,
    Germany

    Active - Recruiting

  • Uniklinik Düsseldorf

    Düsseldorf,
    Germany

    Active - Recruiting

  • KRH Klinikum Siloah

    Hannover,
    Germany

    Active - Recruiting

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

    Köln, 51109
    Germany

    Active - Recruiting

  • Nils Stensen Kliniken, Marienhospital Osnabrück

    Osnabrück,
    Germany

    Active - Recruiting

  • Caritas Klinikum Saarbrücken - St. Theresia

    Saarbrücken,
    Germany

    Active - Recruiting

  • Uniklinik Tübingen

    Tübingen,
    Germany

    Active - Recruiting

  • Asklepios Paulinen Klinik Wiesbaden

    Wiesbaden,
    Germany

    Active - Recruiting

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