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Completed

NCT Number: NCT03419546

Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)

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]).

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Key information

Conditions

Bronchoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

About this study

Muticentric trial to evaluate three outcomes

  • Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.
  • Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.
  • Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. -Opinion of the operator -Quality of the sample

    Time frame: Feb 2018 -july 2018

    1.A numeric scale collects the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.

  2. - Sample quality

    Time frame: Feb 2018- july 2018

    2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Collaborators

  • Ambu A/S

Registry information

Official study title

Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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