Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchoscopy
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Bronchoscope Quality questionnaire evaluation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Bronchoscope Quality questionnaire evaluation
Time Frame: Feb 2018- july 2018
- A numeric scale describes the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.
Secondary Outcomes
- -Opinion of the operator -Quality of the sample(Feb 2018 -july 2018)
- - Sample quality(Feb 2018- july 2018)