Esophageal Achalasia, Esophageal Cancer, Esophageal Diseases, Perforation Esophagus
Conditions
Keywords
Perforation Esophagus, Esophageal Anastomotic Leak,
Brief summary
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
Detailed description
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
Interventions
DEVICEVACStent
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Sponsors
University Hospital of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technique - % of patients with successful implantation of VACStent | 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 | % of patients with successful implantation of VACStent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing of leak - % of patients with successful implantation of VACStent | 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 | % of patients with a sealed leak after successful treatment with VACStent |
| Treatment of sepsis | 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 | % of patients with successful treatment of sepsis leak after successful implantation of VACStent |
| Arrosion of tissue structures | 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 | % of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent |
| Bleeding | 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 | % of patients with bleeding after successful implantation of VACStent |
| Sealing of leak - % of patients with successful implantation of VACStent | 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 | % of patients with a sealed leak after successful treatment with VACStent |
| Migration rate | 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 | % of patients with migration of VACStent after successful implantation of VACStent |
Countries
Germany
Outcome results
None listed