Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy

Erik E. Folch*, Mark R. Bowling, Thomas R. Gildea, Kristin L. Hood, Septimiu D. Murgu, Eric M. Toloza, Momen M. Wahidi, Terence Williams, Sandeep J. Khandhar

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

33 Scopus citations


Background: Electromagnetic navigation bronchoscopy (ENB) procedures allow physicians to access peripheral lung lesions beyond the reach of conventional bronchoscopy. However, published research is primarily limited to small, single-center studies using previous-generation ENB software. The impact of user experience, patient factors, and lesion/procedural characteristics remains largely unexplored in a large, multicenter study. Methods/Design: NAVIGATE (Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy) is a prospective, multicenter, global, cohort study. The study aims to enroll up to 2,500 consecutive subjects presenting for evaluation of lung lesions utilizing the ENB procedure at up to 75 clinical sites in the United States, Europe, and Asia. Subjects will be assessed at baseline, at the time of procedure, and at 1, 12, and 24months post-procedure. The pre-test probability of malignancy will be determined for peripheral lung nodules. Endpoints include procedure-related adverse events, including pneumothorax, bronchopulmonary hemorrhage, and respiratory failure, as well as quality of life, and subject satisfaction. Diagnostic yield and accuracy, repeat biopsy rate, tissue adequacy for genetic testing, and stage at diagnosis will be reported for biopsy procedures. Complementary technologies, such as fluoroscopy and endobronchial ultrasound, will be explored. Success rates of fiducial marker placement, dye marking, and lymph node biopsies will be captured when applicable. Subgroup analyses based on geography, demographics, investigator experience, and lesion and procedure characteristics are planned. Discussion: Study enrollment began in April 2015. As of February 19, 2016, 500 subjects had been enrolled at 23 clinical sites with enrollment ongoing. NAVIGATE will be the largest prospective, multicenter clinical study on ENB procedures to date and will provide real-world experience data on the utility of the ENB procedure in a broad range of clinical scenarios.

Original languageEnglish (US)
Article number60
JournalBMC Pulmonary Medicine
Issue number1
StatePublished - Apr 26 2016


  • Bronchoscopy
  • Electromagnetic navigation
  • Image-guided biopsy
  • Lung cancer
  • Lung neoplasms
  • Neoplasm staging
  • Solitary pulmonary nodule
  • SuperDimension

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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