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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VACStent Group | Experimental | Patient s who received a VACStent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VACStent | Device | Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Hun Chon, M.D. | University Hospital of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31791095 | Background | Chon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available. | |
| 34561712 | Derived |
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| ID | Term |
|---|---|
| D004939 | Esophageal Perforation |
| D004938 | Esophageal Neoplasms |
| D004931 | Esophageal Achalasia |
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014947 | Wounds and Injuries |
| D005770 | Gastrointestinal Neoplasms |
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| 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 |
| Chon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067. |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |