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
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
Condition | Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug |
---|---|
Treatment | The BioSentry Tract Sealant System |
Clinical Study Identifier | NCT03526640 |
Sponsor | University Hospital, Akershus |
Last Modified on | 3 March 2022 |
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