Trials / Completed
CompletedNCT03419546
Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)
Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 216 (actual)
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2018-08-31
- Completion
- 2018-08-31
- First posted
- 2018-02-05
- Last updated
- 2018-10-18
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03419546. Inclusion in this directory is not an endorsement.