Status:
COMPLETED
Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborating Sponsors:
Ambu A/S
Conditions:
Bronchoscopy
Eligibility:
All Genders
18+ years
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 mi...
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 bron...
Eligibility Criteria
Inclusion
- Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study
Exclusion
- No acceptance of the informed consent
- Any procedure out of a low complexity bronchoscopy in the sites of the study
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03419546
Start Date
March 1 2018
End Date
August 31 2018
Last Update
October 18 2018
Active Locations (1)
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1
Fundacion Jimenez Diaz
Madrid, Spain, 28040