Overview

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.

Eligibility

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.