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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03962179
Other study ID # 19-1053_1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 22, 2019
Est. completion date November 30, 2021

Study information

Verified date July 2021
Source University Hospital of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date November 30, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
VACStent
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

Locations

Country Name City State
Germany University Hospital of Cologne Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Chon SH, Bartella I, Bürger M, Rieck I, Goeser T, Schröder 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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