Clinical trial NCT04884334: VAC-Stent Registry
Official title: Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perforation of the Oesophagus
Perforation of the Colon
Keywords: Perforation Oesophagus
Oesophageal Anastomotic Leak
endoscopic vacuum therapy
Perforation Colon
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: VAC Stent GmbH
name: Möller Medical GmbH
name: MicroTech Europe GmbH
name: University of Witten/Herdecke
First posted: 2021-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- accommodation in an institution under court or administrative order

Primary outcomes:
measure: Successful treatment of the leakage with the VAC-Stent®
timeFrame: up to 6 months
Secondary outcomes:
measure: Rate of morphological healing of the insufficiency
timeFrame: approximately 4 weeks after end of treatment
measure: Number of Participants with complications
timeFrame: approximately 4 weeks after end of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Bonn
country: Germany
facility: Johanniter Krankenhaus Bonn
city: Bremerhaven
country: Germany
facility: Ameos Klinikum Am Bürgerpark
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Düsseldorf
country: Germany
facility: Uniklinik Düsseldorf
city: Hannover
country: Germany
facility: KRH Klinikum Siloah
city: Köln
country: Germany
facility: Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital
city: Osnabrück
country: Germany
facility: Nils Stensen Kliniken, Marienhospital Osnabrück
city: Saarbrücken
country: Germany
facility: Caritas Klinikum Saarbrücken - St. Theresia
city: Tübingen
country: Germany
facility: Uniklinik Tübingen
city: Wiesbaden
country: Germany
facility: Asklepios Paulinen Klinik Wiesbaden
Study officials:
References: