Clinical Trial: A Multi-Center Trial of the ProLung Test™

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Fresh Medical Laboratories

Current Primary Outcome: Clinical Efficacy in the risk stratification of patients with indeterminate lesions [ Time Frame: The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained. ]

Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fresh Medical Laboratories

Dates:
Date Received: March 27, 2012
Date Started: October 2012
Date Completion: August 2017
Last Updated: April 20, 2017
Last Verified: April 2017