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

Study Overview
=================
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

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

Conditions
-----------------
Perforation Esophagus, Esophageal Cancer, Esophageal Achalasia, Esophageal Diseases

Intervention / Treatment
-----------------
* Device: VACStent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VACStent Group<br>Patient s who received a VACStent | Device: VACStent<br>* Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technique - % of patients with successful implantation of VACStent | % 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of leak - % of patients with successful implantation of VACStent | % of patients with a sealed leak after successful treatment with 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 | 
| Treatment of sepsis | % of patients with successful treatment of sepsis leak after 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 | 
| Migration rate | % of patients with migration of VACStent after 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 | 
| Bleeding | % of patients with bleeding after 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 | 
| Arrosion of tissue structures | % of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with 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 | 
| Sealing of leak - % of patients with successful implantation of VACStent | % of patients with a sealed leak after successful treatment with 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perforation Esophagus, Esophageal Anastomotic Leak,