NCT03419546

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 minimum training requirements (having performed 100 supervised procedures \[ 10\]) and maintenance of competition (with more than 25 bronchoscopies per year \[10\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

January 19, 2018

Last Update Submit

October 17, 2018

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • -Opinion of the operator -Quality of the sample

    Feb 2018 -july 2018

  • - Sample quality

    Feb 2018- july 2018

Study Arms (1)

Bronchoscopic procedures

Bronchoscopies performed in different sites to evaluate the level of satisfaction of the operators with the device Ambu® aScope™ 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study

You may not qualify if:

  • No acceptance of the informed consent
  • Any procedure out of a low complexity bronchoscopy in the sites of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoscopic lavage with cell analysis

Study Officials

  • Javier Flandes

    Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 5, 2018

Study Start

March 1, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)