Computed Tomography (CT) Guided Lung Biopsy With Plug

Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy

Protocol Title:

Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.

Protocol Summary:

Prospective, randomized, controlled, unblinded, post-market, single-center clinical study

Objectives:

Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).

Primary Objective:

Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy

Secondary Objectives:

Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions

Inclusion Criteria:

1. Provide written informed consent prior to any study related procedure
2. Male or female, aged ≥18 years or older
3. Percutaneous transthoracic needle lung biopsy indicated

Exclusion Criteria:

There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.