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

NCT03993028 | Completed

• 1 other identifier: PL-209
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assess the repeatability of the ProLung Test

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresh Medical Laboratories: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: June 20, 2019
• Study Start: November 20, 2015
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06