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

Clinical Validation Trial of the 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]).

Study Overview

• Status: Completed
• Conditions: Bronchoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Patients that require a low complexity bronchoscopy that accept the informed consent

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bronchoscopic procedures; Bronchoscopies performed in different sites to evaluate the level of satisfaction of the operators with the device Ambu® aScope™ 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.	Feb 2018- july 2018

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Ambu A/S
• Investigators: Principal Investigator: Javier Flandes, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: EO 131/2017_FJD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No