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

Fresh Medical Laboratories

Status: Completed

Conditions: Healthy Volunteers

Study type: Observational

Funder types: Industry

Identifiers

NCT03993028

PL-209

Details and patient eligibility

About

Assess the repeatability of the ProLung Test

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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