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

Completed

• Conditions: Bronchoscopy

• Registration Number: NCT03419546
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief 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 \[10\]).

Detailed 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 Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-03-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchoscope Quality questionnaire evaluation	Feb 2018- july 2018	- A numeric scale describes the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.

Secondary Outcome Measures

Name	Time	Method
-Opinion of the operator -Quality of the sample	Feb 2018 -july 2018	1.A numeric scale collects the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.
- Sample quality	Feb 2018- july 2018	2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.

Trial Locations

Locations (1)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain