Spots Global Cancer Trial Database for Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
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Trial Identification
Brief Title: Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
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
Study ID: NCT03962179
Interventions
Study Description
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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital of Cologne, Cologne, NRW, Germany
Contact Details
Name: Seung-Hun Chon, M.D.
Affiliation: University Hospital of Cologne
Role: PRINCIPAL_INVESTIGATOR
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