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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. efolch@bidmc.harvard.edu.|Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, 185 Pilgrim Road, Deaconess Building, Suite 201, Boston, MA, 02215, USA. efolch@bidmc.harvard.edu.
Erik E
EE
Folch
Department of Internal Medicine, Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, NC, USA.
Mark R
MR
Bowling
Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic Foundation, Cleveland, OH, USA.
Thomas R
TR
Gildea
Medtronic, Mansfield, MA, USA.
Kristin L
KL
Hood
Interventional Pulmonology Fellowship Program, The University of Chicago Medicine, Chicago, IL, USA.
Septimiu D
SD
Murgu
Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Eric M
EM
Toloza
Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Momen M
MM
Wahidi
Department of Radiation Oncology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Terence
T
Williams
CVTSA/Inova Health System, Fairfax Hospital, Falls Church, VA, USA.
Sandeep J
SJ
Khandhar
D001706:Biopsy / Q000379:methods*; D001999:Bronchoscopy / Q000379:methods*; D003937:Diagnosis, Differential; D004574:Electromagnetic Fields; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D008168:Lung / Q000000981:diagnostic imaging*; D008175:Lung Neoplasms / Q000175:diagnosis; D015337:Multicenter Studies as Topic / Q000379:methods*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
Bronchoscopy; Electromagnetic navigation; Image-guided biopsy; Lung cancer; Lung neoplasms; Neoplasm staging; Solitary pulmonary nodule; superDimension