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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
560
The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue.
Haseem Ashraf
Lørenskog, Select A State, Norway
RECRUITINGEvaluate the rate of chest tube
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Time frame: 2 years
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