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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993028
• Other study ID #: PL-209
• Status: Completed
• Start date: November 20, 2015
• Est. completion date: November 21, 2018

Study information

• Verified date: June 2019
• Source: Fresh Medical Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assess the repeatability of the ProLung Test

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fresh Medical Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of participants with device-related adverse events from thoracic bio-conductance measurement.	time to complete scan.	1 day