An observational study in Healthy Volunteers, sponsored by Fresh Medical Laboratories. Completed. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Fresh Medical Laboratories · Observational
Assess the repeatability of the ProLung Test
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.
Fresh Medical Laboratories is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy Volunteers
Exclusion Criteria:
Quantify EPN Scanner variability in transcutaneous volume-averaged thoracic bio-conductance when measured twice on the same subjects by the same operator on a single same day using the same EPN Scanner
The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same day).
Time frame: 1 day
Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week.
The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days).
Time frame: 1 week
Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance
The null hypothesis is that BMI has no effect on scan results. The null hypothesis is that sex has no effect on scan results.
Time frame: 1 week
Number of participants with device-related adverse events from thoracic bio-conductance measurement.
time to complete scan.
Time frame: 1 day
No study locations are listed for this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Fresh Medical Laboratories