Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)

VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment

Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Inclusion Criteria:

• Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
• Accessibility of the leak with the delivery system of the VAC stent

Exclusion Criteria:

• Simultaneous participation in other interventional exams
• Endoscopic inaccessibility of the affected section
• Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
• Unstable patients with severe septic disease, who have a clinical history
• Assessment an immediate operation for safe focus switch-off requires
• Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
• Persons who are in a dependency / employment relationship with the sponsor or examiner stand
• Accommodation in an institution for judicial or regulatory purposes arrangement