Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug Clinical Trial
Official title:
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
;