VACStent study
A prospective feasibility study on the treatment of leakages in the gastrointestinal tract using a combination of a covered Nitinol stent and negative pressure wound treatment
Project overview
Patients with a leak in the oesophagus or colon are treated with a new type of medical device that combines existing treatment options.
The VAC stent consists of a stent made of nitinol filaments encased in a sponge. This is connected to a vacuum pump. This combines the advantages of both systems. This clinical study is investigating the suitability of the VAC stent to seal leaks in the oesophagus. The main aim is to determine whether the VAC stent can be placed just as successfully as a standard stent. The healing process using the VAC stent and possible difficulties or complications are also monitored.
Further information
- Duration: since 2019
- Responsible: Chair of Surgery I
- Further information: The VACStent study is a feasibility study of a CE-certified combination product of two CE-certified medical devices in the intended indication, which also corresponds to the indication of the individual products (study according to §23b MPG). The study is registered in the German Register of Clinical Studies under DRKS00016048.
Project management
Prof. Dr.
Markus Heiss
Chair holder
Faculty of Health (School of Medicine) | Chair of Surgery I
Ostmerheimer Straße 200
51109 Köln
