Cancer , HealthyNCT04134520
Establish ProLung Test Measurement Collection Protocol for Future Studies.
An observational study of Cancer , Healthy, run by Fresh Medical Laboratories at 4 sites in United States.
Trial summary
The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer , Healthy
- What is being tested?
- ProLung System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2020to 16 Oct 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
Who may be able to join
- 7 2.0 Study Objectives 2.1 Objectives and Aims The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure and identify approaches that may be useful in evaluating other cancers in addition to lung cancer. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up cancer validation studies that will assess device accuracy using the new measurement collection methods.
- The Specific Aim of this study:
- Establish the ProLung Test measurement collection protocol for future studies.
- Assess the safety and tolerability of the ProLung Test procedures. 3.0 Study Design This Study Non-Interventional Observational Multi-Site Study in which the ProLung Test does not affect, influence or alter the subject's normal standard of care. The Study will collect data from multiple sites (1- 15). The Study will enroll a minimum of 100 and a maximum 500 subjects. Each subject will receive one or multiple measurement sessions on separate days. 3.1 Safety and Tolerability Information collected about adverse events and tolerability will be analyzed as described in sections 5.8 and 6.0 (Additional Data Collection and Adverse Events). 3.2 Monitoring The study Sponsor will provide monitors to monitor Protocol compliance and provide guidance pertaining to the management of the Study. 4.0 Subject Selection and Participation 4.1 Inclusion Criteria
- Subjects who meet all of the following criteria may be enrolled in this Study:
- Subject is male or female, age 18 or older.
Show all 9Show fewer
- Subjects eligible for enrollment in one of three arms as described herein Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
- Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
- Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
Who cannot join
- The following criteria will disqualify a subject from enrollment into this Study:
- Subject has an implanted electronic device in the chest.
- Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
- Subject will have undergone unusually strenuous exercise within 24 hours.
- Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Coastal Pulmonary Associates
Encinitas, California, 92024
Marilyn Pygott, 760-487-0363, Marilyn.Pygott@coastalpulmonary.com
- Recruiting
Loyola Medical University
Maywood, Illinois, 60153
Jeanne Cecero, 708-216-2058, jcerceo@luc.edu
Amit Goyal, M.D.
- Recruiting
Ogden Regional Medical Center
Ogden, Utah, 84405
Brittny Miller, 801-389-3748, Brittny.miller@mountainstarhealth.com
Jose Perez-Tomayo, M.D.
- Recruiting
Michael Garff
Salt Lake City, Utah, 84103
Michael Garff, 801-204-9625, mag@prolunginc.com
Rex Yung, M.D.
About this study
Official title: PL-210: Establish ProLung Test Measurement Collection Protocol for Future Studies.
The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new measurement collection methods.
- Conditions
- Cancer , Healthy
- Being tested
- ProLung System
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProLung SystemDevice
Non-invasive bioconductance measurements
| Study group | Role | What they receive |
|---|---|---|
| Generally healthy subjects with no known cancer disorder | Not described Receives: Device: ProLung System | |
| Subjects with a pathological diagnosis of cancer | Not described Receives: Device: ProLung System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the ProLung Test measurement collection protocol for future studies.
The study will evaluate several data collection methodologies including the China CFDA Study method which utilizes diaphoretic electrodes as the reference electrode at measurement point locations and other methods using brass reference electrode at point locations. In addition, the benefits of obtaining multiple repeat measurements will be evaluated.
Measured: 1 day
Secondary outcomes (1)
Assess the safety and tolerability of the ProLung Test procedures
Adverse events will be recorded and following the ProLung Test, subjects will be asked to complete a brief questionnaire regarding their experience and perception of the procedure. The questions are:
- Did the test cause any discomfort? If so, please describe.
- Did the time required for measurement seem too long? If so, what amount of time seems reasonable?
- Would you undergo measurement again? If so, please describe
- Do you have any suggestions for improving the measurement procedure? If so, please describe.
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 posted22 Oct 2019
- Study start14 Feb 2020
- Primary completion16 Oct 2024 (estimated)
- Study completion16 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer , HealthyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresh Medical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134520
- Sponsor's protocol ID
- PL 210
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PL-210: Establish ProLung Test Measurement Collection Protocol for Future Studies.
- ClinicalTrials.gov ID
- NCT04134520
- Acronym / sponsor ID
- PL 210
- Conditions
- Cancer , Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fresh Medical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 16 Oct 2024 (estimated)
- Study completion
- 16 Oct 2024 (estimated)
- First posted
- 22 Oct 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.
The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new measurement collection methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generally healthy subjects with no known cancer disorder | – | Device: ProLung System |
| Subjects with a pathological diagnosis of cancer | – | Device: ProLung System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
Key inclusion criteria (9 listed)
- 7 2.0 Study Objectives 2.1 Objectives and Aims The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure and identify approaches that may be useful in evaluating other cancers in addition to lung cancer. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up cancer validation studies that will assess device accuracy using the new measurement collection methods.
- Establish the ProLung Test measurement collection protocol for future studies.
- Assess the safety and tolerability of the ProLung Test procedures. 3.0 Study Design This Study Non-Interventional Observational Multi-Site Study in which the ProLung Test does not affect, influence or alter the subject's normal standard of care. The Study will collect data from multiple sites (1- 15). The Study will enroll a minimum of 100 and a maximum 500 subjects. Each subject will receive one or multiple measurement sessions on separate days. 3.1 Safety and Tolerability Information collected about adverse events and tolerability will be analyzed as described in sections 5.8 and 6.0 (Additional Data Collection and Adverse Events). 3.2 Monitoring The study Sponsor will provide monitors to monitor Protocol compliance and provide guidance pertaining to the management of the Study. 4.0 Subject Selection and Participation 4.1 Inclusion Criteria
- Subject is male or female, age 18 or older.
- Subjects eligible for enrollment in one of three arms as described herein Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
Key exclusion criteria (5 listed)
- Subject has an implanted electronic device in the chest.
- Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
- Subject will have undergone unusually strenuous exercise within 24 hours.
- Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProLung SystemNon-invasive bioconductance measurements | Device | Generally healthy subjects with no known cancer disorder, Subjects with a pathological diagnosis of cancer |
Primary outcome
Establish the ProLung Test measurement collection protocol for future studies.
Time frame: 1 day
The study will evaluate several data collection methodologies including the China CFDA Study method which utilizes diaphoretic electrodes as the reference electrode at measurement point locations and other methods using brass reference electrode at point locations. In addition, the benefits of obtaining multiple repeat measurements will be evaluated.
1 secondary outcome
Assess the safety and tolerability of the ProLung Test procedures
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer , Healthy, run by Fresh Medical Laboratories at 4 sites in United States.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Garff (385.501.7002, mag@prolunginc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the ProLung Test measurement collection protocol for future studies. (time frame: 1 day). 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 25 Oct 2022.