- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03993028
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
June 18, 2019 updated by: Fresh Medical Laboratories
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
Assess the repeatability of the ProLung Test
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy Volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
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).
|
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.
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).
|
1 week
|
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.
|
1 week
|
Number of participants with device-related adverse events from thoracic bio-conductance measurement.
Time Frame: 1 day
|
time to complete scan.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2015
Primary Completion (Actual)
November 21, 2018
Study Completion (Actual)
November 21, 2018
Study Registration Dates
First Submitted
November 25, 2015
First Submitted That Met QC Criteria
June 18, 2019
First Posted (Actual)
June 20, 2019
Study Record Updates
Last Update Posted (Actual)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 18, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- PL-209
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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