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A novel flexible 19G EBUS-TBNA needle: Absolute and relative performance in patients

Anna Sczaniecka, Xavier Gonzalez, Lina Zuccatosta, Stefano Gasparini, Daniela Gompelmann, Felix Herth, Samuel Kemp, Pallav Shah, Maciej Gnass, Artur Szlubowski
European Respiratory Journal 2016 48: PA2036; DOI: 10.1183/13993003.congress-2016.PA2036
Anna Sczaniecka
1Research, Olympus Respiratory America, Redmond, United States
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Xavier Gonzalez
1Research, Olympus Respiratory America, Redmond, United States
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Lina Zuccatosta
2Pulmonary Diseases Unit, Department of Internal Medicine, Azienda Ospedali Riuniti, Ancona, Italy
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Stefano Gasparini
2Pulmonary Diseases Unit, Department of Internal Medicine, Azienda Ospedali Riuniti, Ancona, Italy
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Daniela Gompelmann
3Department of Pneumology and Respiratory Critical Care Medicine, Center for Interstitial and Rare Lung Diseases, Thoraxklinik, Heidelberg, Germany
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Felix Herth
3Department of Pneumology and Respiratory Critical Care Medicine, Center for Interstitial and Rare Lung Diseases, Thoraxklinik, Heidelberg, Germany
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Samuel Kemp
4Department of Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom
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Pallav Shah
4Department of Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom
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Maciej Gnass
5Endoscopy Unit, Pulmonary Hospital, Zakopane, Poland
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Artur Szlubowski
5Endoscopy Unit, Pulmonary Hospital, Zakopane, Poland
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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.

  • Bronchoscopy
  • Lung cancer / Oncology
  • Copyright ©the authors 2016
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A novel flexible 19G EBUS-TBNA needle: Absolute and relative performance in patients
Anna Sczaniecka, Xavier Gonzalez, Lina Zuccatosta, Stefano Gasparini, Daniela Gompelmann, Felix Herth, Samuel Kemp, Pallav Shah, Maciej Gnass, Artur Szlubowski
European Respiratory Journal Sep 2016, 48 (suppl 60) PA2036; DOI: 10.1183/13993003.congress-2016.PA2036

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A novel flexible 19G EBUS-TBNA needle: Absolute and relative performance in patients
Anna Sczaniecka, Xavier Gonzalez, Lina Zuccatosta, Stefano Gasparini, Daniela Gompelmann, Felix Herth, Samuel Kemp, Pallav Shah, Maciej Gnass, Artur Szlubowski
European Respiratory Journal Sep 2016, 48 (suppl 60) PA2036; DOI: 10.1183/13993003.congress-2016.PA2036
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