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

Esophageal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962179
• Other study ID #: 19-1053_1
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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

External Links

•   A Novel Hybrid Stent with Endoscopic Vacuum Therapy for Treating Leaks of the Upper Gastrointestinal Tract