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

University Hospital of Cologne

Status

Unknown

Conditions

Esophageal Cancer

Perforation Esophagus

Esophageal Diseases

Esophageal Achalasia

Treatments

Device: VACStent

Study type

Interventional

Funder types

Other

Identifiers

NCT03962179

19-1053_1

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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