VAC-Stent Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Perforation of the Oesophagus Perforation of the Colon

Keywords

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Perforation Oesophagus Oesophageal Anastomotic Leak endoscopic vacuum therapy Perforation Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VAC-Stent® treatment

spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon

VAC-Stent®

Intervention Type DEVICE

treatment with the VAC-Stent®

Interventions

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VAC-Stent®

treatment with the VAC-Stent®

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- accommodation in an institution under court or administrative order

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Markus M. Heiss

Prof Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Charité

Berlin, , Germany

Site Status RECRUITING

Sana Klinikum Lichtenberg

Berlin, , Germany

Site Status RECRUITING

St. Josef-Hospital

Bochum, , Germany

Site Status RECRUITING

Johanniter Krankenhaus Bonn

Bonn, , Germany

Site Status RECRUITING

Ameos Klinikum Am Bürgerpark

Bremerhaven, , Germany

Site Status RECRUITING

Allgemeines Krankenhaus Celle

Celle, , Germany

Site Status RECRUITING

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

Cologne, , Germany

Site Status RECRUITING

Städtisches Klinikum Dresden

Dresden, , Germany

Site Status RECRUITING

Uniklinik Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

KRH Klinikum Siloah

Hanover, , Germany

Site Status RECRUITING

Nils Stensen Kliniken, Marienhospital Osnabrück

Osnabrück, , Germany

Site Status RECRUITING

Caritas Klinikum Saarbrücken - St. Theresia

Saarbrücken, , Germany

Site Status RECRUITING

Uniklinik Tübingen

Tübingen, , Germany

Site Status RECRUITING

Asklepios Paulinen Klinik Wiesbaden

Wiesbaden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus M Heiss, Prof Dr

Role: CONTACT

Phone: +4922189073771

Email: [email protected]

Facility Contacts

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Markus M Heiss, Prof Dr

Role: primary

References

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Heiss MM, Lange J, Knievel J, Yohannes A, Hugle U, Dormann AJ, Eisenberger CF. Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study. Langenbecks Arch Surg. 2024 Jul 31;409(1):234. doi: 10.1007/s00423-024-03426-5.

Reference Type DERIVED

PMID: 39083099 (View on PubMed)

Lange J, Knievel J, Wichmann D, Kahler G, Wiedbrauck F, Hellmich T, Kandler M, Bernhardt J, Scholz D, Beyna T, Hausmann J, Wedi E, Ellrichmann M, Hugle U, Dormann AJ, Eisenberger CF, Heiss MM. Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept. Front Surg. 2023 May 5;10:1182094. doi: 10.3389/fsurg.2023.1182094. eCollection 2023.

Reference Type DERIVED

PMID: 37215348 (View on PubMed)

Other Identifiers

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