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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Technique - % of patients with successful implantation of VACStent
% of patients with successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Healing of leak - % of patients with successful implantation of VACStent
% of patients with a sealed leak after successful treatment with VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Treatment of sepsis
% of patients with successful treatment of sepsis leak after successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Migration rate
% of patients with migration of VACStent after successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Bleeding
% of patients with bleeding after successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Arrosion of tissue structures
% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Sealing of leak - % of patients with successful implantation of VACStent
% of patients with a sealed leak after successful treatment with VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months