Healthy VolunteersNCT03993028
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
An observational study of Healthy Volunteers, run by Fresh Medical Laboratories.
Trial summary
Assess the repeatability of the ProLung Test Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2015to 21 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Age 35 to 70 years
- Able to understand and fulfill all requirements of this protocol
- Provide signed informed consent
Who cannot join
- 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
About this study
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
Assess the repeatability of the ProLung Test
Read the 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.
- Conditions
- Healthy Volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 1 week
Number of participants with device-related adverse events from thoracic bio-conductance measurement.
time to complete scan.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start20 Nov 2015
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresh Medical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993028
- Sponsor's protocol ID
- PL-209
- Status last verified
- Jun 2019
- First submitted
- 25 Nov 2015
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03993028
- Acronym / sponsor ID
- PL-209
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fresh Medical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the repeatability of the ProLung Test
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (3 listed)
- Age 35 to 70 years
- Able to understand and fulfill all requirements of this protocol
- Provide signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Fresh Medical Laboratories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.