DRKS00016048
Recruiting
N/A
A prospective feasibility study on the treatment of gastrointestinal leakage by the use of combination of covered nitinol stent and negative pressure wound treatment - VAC-Stent
Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Klinikum Köln-Merheim0 sites30 target enrollmentJanuary 22, 2019
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- K22.3
- Sponsor
- Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Klinikum Köln-Merheim
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Presence of a written consent of the patient
- •Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus
- •Accessibility of the leakage with the delivery system of the VAC stent
Exclusion Criteria
- •Simultaneous participation in other interventional trials
- •Endoscopic inaccessibility of the affected section
- •Full anticoagulation with INR \> 1\.5 and/or PTT \> 50 sec, or platelets \< 20\.000/µl (after therapeutic correction an inclusion is possible)
- •Unstable patients with a severe septic condition who require an immediate operation
- •ileus image with constant vomiting (after gastric tube and gastric emptyingan inclusion is possible)
- •Persons who are in a dependency / employment relationship with the sponsor or investigator
- •Accommodation in an institution under court or administrative order
Outcomes
Primary Outcomes
Not specified
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