Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)

Status Completed

Clinical Trial Summary

The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope, in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists who meet the minimum training requirements (having performed 100 supervised procedures [ 10]) and maintenance of competition (with more than 25 bronchoscopies per year [10]).

Clinical Trial Description

Muticentric trial to evaluate three outcomes

1. Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.

2. Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.

3. Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope. ;

Study Design

Related Conditions & MeSH terms

Bronchoscopy

Clinical Trial Details

NCT number	NCT03419546
Study type	Observational
Source	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact
Status	Completed
Phase
Start date	March 1, 2018
Completion date	August 31, 2018

View Details

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