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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-22

Study Completion Date

2021-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Perforation Esophagus Esophageal Cancer Esophageal Achalasia Esophageal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VACStent Group

Patient s who received a VACStent

Group Type EXPERIMENTAL

VACStent

Intervention Type DEVICE

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

Interventions

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VACStent

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No