|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 February 2016 |
|
Main ID: |
NCT02228018 |
|
Date of registration:
|
25/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
|
|
Scientific title:
|
The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02228018 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Wilfried De Backer, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Antwerp |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male or female patient / volunteer = 18 years old
- Written informed consent obtained
- The subject belongs to 1 of the following groups in the opinion of the investigator:
Group 1: healthy volunteer Group 2: patient with asthma
- Only if patient/ volunteer is a female of childbearing potential: Confirmation that a
contraception method was used at least 14 days before visit 1
Exclusion Criteria:
- Pregnant or lactating female
- Patient/ volunteer with an uncontrolled disease or any condition that might, in the
judgement of the investigator, place the patient at undue risk or potentially
compromise the results or interpretation of the study.
Patient/ volunteer with an uncontrolled disease or any condition that might, in the
judgement of the investigator, place the patient at undue risk or potentially compromise
the results or interpretation of the study.
Age minimum:
18 Years
Age maximum:
120 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Asthma
|
|
Intervention(s)
|
|
Device: CT-scan
|
|
Primary Outcome(s)
|
|
CALSA
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
Lobar Volume
[Time Frame: 1 day]
|
|
Total Airway Resistance (iRaw)
[Time Frame: 1 day]
|
|
Internal Airway Distribution
[Time Frame: 1 day]
|
|
Total Airway Volume (iVaw)
[Time Frame: 1 day]
|
|
Secondary ID(s)
|
|
FLUI-2014-118
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|