title: Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.
abstract: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.
  
  
  
  NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.
  
  
  
  ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.
  
  
  
  One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.
  
  
  
  ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
authors.affiliation: Inova Health System, Fairfax Hospital, Falls Church, VA, USA.
authors.forename: Sandeep J
authors.initials: SJ
authors.lastname: Khandhar
authors.affiliation: East Carolina University, Greenville, NC, USA.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Bowling
authors.affiliation: Pulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Flandes
authors.affiliation: Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Gildea
authors.affiliation: Medtronic, Minneapolis, MN, USA.
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Hood
authors.affiliation: Pulmonary and Critical Care Associates of Baltimore, Baltimore, MD, USA.
authors.forename: William S
authors.initials: WS
authors.lastname: Krimsky
authors.affiliation: Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.|Present Address: Princeton Baptist Medical Center, Birmingham, AL, USA.
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Minnich
authors.affiliation: Interventional Pulmonology Fellowship Program, The University of Chicago Medicine, Chicago, IL, USA.
authors.forename: Septimiu D
authors.initials: SD
authors.lastname: Murgu
authors.affiliation: Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, NC, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Pritchett
authors.affiliation: Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA.|Department of Surgery and Department of Oncologic Sciences, University of South Florida Morsani College of Medicine, Tampa, FL, USA.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Toloza
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Momen M
authors.initials: MM
authors.lastname: Wahidi
authors.affiliation: Medtronic, Minneapolis, MN, USA.
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Wolvers
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Bulfinch 148, Boston, MA, 02114, USA. efolch@mgh.harvard.edu.
authors.forename: Erik E
authors.initials: EE
authors.lastname: Folch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001999:Bronchoscopy / Q000379:methods*; D003937:Diagnosis, Differential; D055590:Electromagnetic Phenomena; D005060:Europe; D005260:Female; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods; D008168:Lung / Q000473:pathology*; D008175:Lung Neoplasms / Q000175:diagnosis*; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011030:Pneumothorax / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D014481:United States; D055815:Young Adult
keywords: Image-Guided Biopsy; Lung Cancer; Lung Neoplasms; Neoplasm Staging; Solitary Pulmonary Nodule