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

Not Applicable

• Conditions: Perforation Esophagus; Esophageal Cancer; Esophageal Achalasia; Esophageal Diseases
• Interventions: Device: VACStent

• Registration Number: NCT03962179
• Lead Sponsor: University Hospital of Cologne

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

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Study Start: 2019-09-22
• Primary Completion: 2020-11-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-05
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VACStent Group	VACStent	Patient s who received a VACStent

Primary Outcome Measures

Name	Time	Method
Technique - % 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	% of patients with successful implantation of VACStent

Secondary Outcome Measures

Name	Time	Method
Healing of leak - % 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	% of patients with a sealed leak after successful treatment with VACStent
Treatment of sepsis	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	% of patients with successful treatment of sepsis leak after successful implantation of VACStent
Migration rate	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	% of patients with migration of VACStent after successful implantation of VACStent
Bleeding	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	% of patients with bleeding after successful implantation of VACStent
Arrosion of tissue structures	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	% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent
Sealing of leak - % 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	% of patients with a sealed leak after successful treatment with VACStent

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, NRW, Germany