Establish ProLung Test Measurement Collection Protocol for Future Studies.
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|ClinicalTrials.gov Identifier: NCT04134520|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 25, 2022
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|Condition or disease||Intervention/treatment|
|Cancer , Healthy||Device: ProLung System|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
|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
- 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.
- 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:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Probability Sample|
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.
- 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").
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.
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
|Contact: Michael Garfffirstname.lastname@example.org|
|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 email@example.com|
|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.firstname.lastname@example.org|
|Principal Investigator: Jose Perez-Tomayo, M.D.|
|Salt Lake City, Utah, United States, 84103|
|Contact: Michael Garff 801-204-9625 email@example.com|
|Principal Investigator: Rex Yung, M.D.|
|Responsible Party:||Fresh Medical Laboratories|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|