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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
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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]).
Muticentric trial to evaluate three outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchoscopic procedures | Bronchoscopies performed in different sites to evaluate the level of satisfaction of the operators with the device Ambu® aScope™ 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| -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 |
| - Sample quality |
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Inclusion Criteria:
Exclusion Criteria:
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- Patients that require a low complexity bronchoscopy that accept the informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Javier Flandes | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
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Bronchoscopic lavage with cell analysis
2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.
| Feb 2018- july 2018 |