Registry for the VAC-Stent used in gastrointestinal leak treatment
Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
This study is collecting information on the VAC-Stent®, a device that helps seal leaks in the esophagus and colon, to see how safe and effective it is for patients with these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Witten/Herdecke Academic / other |
| Locations | 14 sites (Berlin and 13 other locations) |
| Trial ID | NCT04884334 on ClinicalTrials.gov |
What this trial studies
This registry collects quality assurance data on the VAC-Stent®, a medical device designed to seal leaks in the oesophagus and colon. The VAC-Stent® combines a vacuum sponge and a covered stent to address common issues associated with traditional stents and vacuum therapy. By prospectively gathering data from patients treated with the VAC-Stent®, the study aims to evaluate its safety and efficacy in clinical settings. The registry will help verify the device's suitability for managing gastrointestinal perforations and leaks.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients who require treatment for perforations in the oesophagus or colon and consent to the use of the VAC-Stent®.
Not a fit: Patients who are under court or administrative order and cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a safer and more effective treatment option for patients with gastrointestinal leaks.
How similar studies have performed: While the VAC-Stent® represents a novel approach, similar studies on endoscopic treatments for gastrointestinal leaks have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * written informed consent * treatment with the VAC-Stent® Exclusion Criteria: - accommodation in an institution under court or administrative order
Where this trial is running
Berlin and 13 other locations
- Charité — Berlin, Germany (Recruiting)
- Sana Klinikum Lichtenberg — Berlin, Germany (Recruiting)
- St. Josef-Hospital — Bochum, Germany (Recruiting)
- Johanniter Krankenhaus Bonn — Bonn, Germany (Recruiting)
- Ameos Klinikum Am Bürgerpark — Bremerhaven, Germany (Recruiting)
- Allgemeines Krankenhaus Celle — Celle, Germany (Recruiting)
- Städtisches Klinikum Dresden — Dresden, Germany (Recruiting)
- Uniklinik Düsseldorf — Düsseldorf, Germany (Recruiting)
- KRH Klinikum Siloah — Hannover, Germany (Recruiting)
- Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital — Köln, Germany (Recruiting)
- Nils Stensen Kliniken, Marienhospital Osnabrück — Osnabrück, Germany (Recruiting)
- Caritas Klinikum Saarbrücken - St. Theresia — Saarbrücken, Germany (Recruiting)
- Uniklinik Tübingen — Tübingen, Germany (Recruiting)
- Asklepios Paulinen Klinik Wiesbaden — Wiesbaden, Germany (Recruiting)
Study contacts
- Study coordinator: Markus M Heiss, Prof Dr
- Email: HeissM@kliniken-koeln.de
- Phone: +4922189073771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.