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

Assess the repeatability of the ProLung Test

Completed

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Key information

Conditions

Healthy Volunteers

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 35 to 70 years
Able to understand and fulfill all requirements of this protocol
Provide signed informed consent

Exclusion criteria

Pacemaker or other implanted medical device
Current life-threatening medical condition
Current or recent use of systemic corticosteroids
Pregnant or lactating
Unusually strenuous exercise within previous 24 hours
Current abuse of alcohol or drugs
Medical or anatomical condition that precludes testing of all 62 measurement points
Other condition or reason at the discretion of the Principal Investigator or medical monitor

Treatment and study plan

Primary outcomes

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

Time frame: 1 day

The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same 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.

Time frame: 1 week

The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days).
Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance

Time frame: 1 week

The null hypothesis is that BMI has no effect on scan results. The null hypothesis is that sex has no effect on scan results.
Number of participants with device-related adverse events from thoracic bio-conductance measurement.

Time frame: 1 day

time to complete scan.

Sponsors and collaborators

Lead sponsor

Fresh Medical Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Jun 20, 2019
Registry last updated: Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed