A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer
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. Subject has undergone CT scan of the lung(s) that indicates one or more non-calcified
nodules or lesions suspicious for lung cancer.
3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the
largest nodule or lesion dimension identified from CT imaging.
4. Subject is indicated for a tissue biopsy of the lung.
5. Subject must be able to receive a ProLung Test within 60 days of abnormal CT
(Inclusion Criterion 2 & 3) or within 60 days prior to the tissue biopsy (Inclusion
6. Subject is capable of understanding and agreeing to fulfill the requirements of this
7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
The following criteria will disqualify a subject from enrollment into this Study:
1. Subject has an implanted electronic device in the chest.
2. Subject receiving therapy for suspected chest infection such as fungal infection or
3. Subject with diagnosed malignancy within the past 5 (five) years except for
non-melanoma skin cancer and lung cancer.
4. Subject has received systemic corticosteroid medication within 14 days prior to
ProLung Test (except for ophthalmic preparations or inhaled medications used more
than 4 hours prior to ProLung Test).
5. Subject has received an invasive medical or surgical procedure within the thoracic
cavity within 30 days prior to the ProLung Test or within the previous 14 days for a
6. Subject presents with an anomalous physical or anatomical condition that precludes
ProLung Test measurement.
7. Subject will have undergone unusually strenuous exercise within 24 hours.
8. 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.