Bronchoscopy Clinical Trial
Official title:
Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4
Verified date | October 2018 |
Source | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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]).
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Jimenez Diaz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Ambu A/S |
Spain,
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 |
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