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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. | 1 week |
| Number of participants with device-related adverse events from thoracic bio-conductance measurement. | time to complete scan. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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