Establish ProLung Test Measurement Collection Protocol for Future Studies.

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer , Healthy
• Intervention / Treatment: Device: ProLung System

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Michael Garff; Phone Number: 385.501.7002; Email: mag@prolunginc.com

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • Coastal Pulmonary Associates
      • Contact: Marilyn Pygott; Phone Number: 760-487-0363; Email: Marilyn.Pygott@coastalpulmonary.com
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Recruiting
      • Loyola Medical University
      • Contact: Jeanne Cecero; Phone Number: 708-216-2058; Email: jcerceo@luc.edu
      • Principal Investigator: Amit Goyal, M.D.
  • Utah
    • Ogden, Utah, United States, 84405
      • Recruiting
      • Ogden Regional Medical Center
      • Contact: Brittny Miller; Phone Number: 801-389-3748; Email: Brittny.miller@mountainstarhealth.com
      • Principal Investigator: Jose Perez-Tomayo, M.D.
    • Salt Lake City, Utah, United States, 84103
      • Recruiting
      • Michael Garff
      • Contact: Michael Garff; Phone Number: 801-204-9625; Email: mag@prolunginc.com
      • Principal Investigator: Rex Yung, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Fresh Medical Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Anticipated): October 16, 2024
• Study Completion (Anticipated): October 16, 2024

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PL 210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes