BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures

This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.

Inclusion Criteria:

• The patient must meet all medical conditions for lung biopsy;
• The patient must be at least 18 years of age;
• The patient, or legal representative, must understand and provide written consent for the procedure;
• The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.

Exclusion Criteria:

• Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
• Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
• Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
• Patients who are uncooperative or cannot follow instructions.
• Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.