Solitary Pulmonary Nodule Clinical Trial
Official title:
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
The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in
the risk stratification of patients with pulmonary lesions identified by CT that are
suspicious for lung cancer. A statistically significant result will indicate that patients
with a high ProLung Test result have a greater risk of developing lung cancer than patients
with a low test result.
There are three Specific Aims of this study:
1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in
patients with a diagnosis.
2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by
comparing the test result to the conclusive patient diagnosis.
3. Assess the safety and tolerability of the ProLung Test procedures.
Study Design This Study consists of two distinct phases, Stabilization and Validation. The
Study will collect data from multiple sites (3 to 12), and each site may enroll patients and
collect data for the Stabilization and Validation Phases with a minimum of three sites for
the Validation Phase.
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