NCT03962179

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Perforation Esophagus
• Esophageal Cancer
• Esophageal Achalasia
• Esophageal Diseases

Interventions

Type	Name	Description
DEVICE	VACStent	Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

Timeline

• Start date: 2019-09-22
• Primary completion: 2020-11-30
• Completion: 2021-11-30
• First posted: 2019-05-23
• Last updated: 2021-08-05

Locations

1 site across 1 country: Germany