Abstract
Introduction: Endobronchial Ultrasound guided Trans-bronchial Needle Aspiration, (EBUS-TBNA) is used for the diagnosis and/or staging of cancer and other disorders. A novel 19G EBUS-TBNA needle ([Olympus Respiratory America], Redmond, WA, USA) with a larger diameter was developed to collect larger samples.
Aims and Objectives: Evaluations were done in patients to assess the performance of the new 19G EBUS-TBNA needle.
Methods: Product performance evaluations were conducted in 4 countries by 13 physicians experienced with EBUS-TBNA from Sept 2015 to Nov 2015. Physicians in each country were provided with 20 needles and asked to evaluate their performance in patients by completing evaluation forms.
The forms asked physicians to rate the needles' absolute (stand-alone) and relative performance (with respect to their experience of using current commercially available 21G and 22G needles) in the areas of penetration, visibility, and sample collection. Eighty completed evaluation forms were returned and analyzed.
Results: For relative performance, physicians rated the 19G needle as comparable or better on 97.5% of the forms for sample collection, 92.5% for penetration, and 95% for visibility. For absolute performance, physicians rated the ability of the device to collect samples, its penetration, and its visibility as acceptable 98.75%, 97.5%, and 97.5% of the time respectively. One subject in Poland experienced bleeding after puncturing of the right hilum.
Conclusions: Product performance evaluations of the 19G needle suggest that its performance is equivalent to or better than currently commercially available needles. However, additional clinical evaluations are warranted.
- Copyright ©the authors 2016
