Trials / Completed
CompletedNCT03993028
The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability for the ProLung Test and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Fresh Medical Laboratories · Industry
- Sex
- All
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Assess the repeatability of the ProLung Test
Detailed description
This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same device. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested.
Conditions
Timeline
- Start date
- 2015-11-20
- Primary completion
- 2018-11-21
- Completion
- 2018-11-21
- First posted
- 2019-06-20
- Last updated
- 2019-06-20
Source: ClinicalTrials.gov record NCT03993028. Inclusion in this directory is not an endorsement.