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

Bronchoscopy Clinical Trial

Official title:

Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419546
• Other study ID #: EO 131/2017_FJD
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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]).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Ambu A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchoscope Quality questionnaire evaluation	- A numeric scale describes the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.	Feb 2018- july 2018
Secondary	-Opinion of the operator -Quality of the sample	1.A numeric scale collects the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.	Feb 2018 -july 2018
Secondary	- Sample quality	2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.	Feb 2018- july 2018