VAC-Stent Registry

Recruiting

• Conditions: Perforation of the Oesophagus; Perforation of the Colon
• Interventions: Device: VAC-Stent®

• Registration Number: NCT04884334
• Lead Sponsor: Markus M. Heiss

Brief 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.

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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• accommodation in an institution under court or administrative order

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VAC-Stent® treatment	VAC-Stent®	spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon

Primary Outcome Measures

Name	Time	Method
Successful treatment of the leakage with the VAC-Stent®	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with complications	approximately 4 weeks after end of treatment
Rate of morphological healing of the insufficiency	approximately 4 weeks after end of treatment

Trial Locations

Locations (14)

Charité; 🇩🇪 Berlin, Germany

Sana Klinikum Lichtenberg; 🇩🇪 Berlin, Germany

St. Josef-Hospital; 🇩🇪 Bochum, Germany

Uniklinik Düsseldorf; 🇩🇪 Düsseldorf, Germany

KRH Klinikum Siloah; 🇩🇪 Hannover, Germany

Nils Stensen Kliniken, Marienhospital Osnabrück; 🇩🇪 Osnabrück, Germany

Caritas Klinikum Saarbrücken - St. Theresia; 🇩🇪 Saarbrücken, Germany

Johanniter Krankenhaus Bonn; 🇩🇪 Bonn, Germany

Ameos Klinikum Am Bürgerpark; 🇩🇪 Bremerhaven, Germany

Allgemeines Krankenhaus Celle; 🇩🇪 Celle, Germany

Städtisches Klinikum Dresden; 🇩🇪 Dresden, Germany

Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital; 🇩🇪 Köln, Germany

Uniklinik Tübingen; 🇩🇪 Tübingen, Germany

Asklepios Paulinen Klinik Wiesbaden; 🇩🇪 Wiesbaden, Germany