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Establish ProLung Test Measurement Collection Protocol for Future Studies.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134520
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Fresh Medical Laboratories

Study Description
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Brief 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 measurement collection methods.

Condition or disease Intervention/treatment
Cancer , Healthy Device: ProLung System

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PL-210: Establish ProLung Test Measurement Collection Protocol for Future Studies.
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : October 16, 2024
Estimated Study Completion Date : October 16, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Generally healthy subjects with no known cancer disorder Device: ProLung System
Non-invasive bioconductance measurements
Subjects with a pathological diagnosis of cancer Device: ProLung System
Non-invasive bioconductance measurements


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assess the safety and tolerability of the ProLung Test procedures [ Time Frame: 1 day ]

    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:

    1. Did the test cause any discomfort? If so, please describe.
    2. Did the time required for measurement seem too long? If so, what amount of time seems reasonable?
    3. Would you undergo measurement again? If so, please describe
    4. Do you have any suggestions for improving the measurement procedure? If so, please describe.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

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:

  1. Establish the ProLung Test measurement collection protocol for future studies.
  2. 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:

  1. Subject is male or female, age 18 or older.
  2. 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
  3. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
  4. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

Exclusion Criteria:

The following criteria will disqualify a subject from enrollment into this Study:

  1. Subject has an implanted electronic device in the chest.
  2. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
  3. Subject will have undergone unusually strenuous exercise within 24 hours.
  4. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134520


Contacts
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Contact: Michael Garff 385.501.7002 mag@prolunginc.com

Locations
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United States, California
Coastal Pulmonary Associates Recruiting
Encinitas, California, United States, 92024
Contact: Marilyn Pygott    760-487-0363    Marilyn.Pygott@coastalpulmonary.com   
United States, Illinois
Loyola Medical University Recruiting
Maywood, Illinois, United States, 60153
Contact: Jeanne Cecero    708-216-2058    jcerceo@luc.edu   
Principal Investigator: Amit Goyal, M.D.         
United States, Utah
Ogden Regional Medical Center Recruiting
Ogden, Utah, United States, 84405
Contact: Brittny Miller    801-389-3748    Brittny.miller@mountainstarhealth.com   
Principal Investigator: Jose Perez-Tomayo, M.D.         
Michael Garff Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Michael Garff    801-204-9625    mag@prolunginc.com   
Principal Investigator: Rex Yung, M.D.         
Sponsors and Collaborators
Fresh Medical Laboratories
More Information
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Responsible Party: Fresh Medical Laboratories
ClinicalTrials.gov Identifier: NCT04134520    
Other Study ID Numbers: PL 210
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes