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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Completed

Conditions: Bronchoscopy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03419546

EO 131/2017_FJD

Details and patient eligibility

About

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]).

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study

Exclusion criteria

• No acceptance of the informed consent
• Any procedure out of a low complexity bronchoscopy in the sites of the study

Trial design

216 participants in 1 patient group

Bronchoscopic procedures

Description:

Bronchoscopies performed in different sites to evaluate the level of satisfaction of the operators with the device Ambu® aScope™ 4