Abstract
BackgroundElectromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.MethodsNAVIGATE 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.ResultsENB 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.ConclusionsOne-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.Trial registrationClinicalTrials.gov NCT02410837. Registered 31 March 2015.
Highlights
Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions
At least 10% of the data are verified against source files by the sponsor using risk-based monitoring. Participants This prespecified interim analysis includes the first 1,000 primary cohort subjects enrolled at 29 clinical sites in the United States (27 sites) and Europe from April 16, 2015 to June 27, 2016 (Fig. 1, and Additional file 3)
One-month follow-up was completed in 93.3% of subjects
Summary
Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. Utilization of electromagnetic navigation bronchoscopy (ENB) has increased over the past ten years as a minimally invasive approach to complement traditional bronchoscopy, endobronchial ultrasound (EBUS), and image-guided transthoracic biopsy. The pragmatic design [6] of NAVIGATE maximizes patient eligibility, usual care settings, flexibility of adherence, and a relevant primary outcome for clinical practice. The detailed prospective collection of data minimizes retrospective bias and allows future multivariate analyses to provide more meaningful information on the variable utilization of this technology into real-world practice and its impact on measurable outcomes, such as diagnostic yield and risk. A heterogeneous dataset will be instructive for the design of potential comparative studies with respect to operator training, subject inclusion criteria, data to be collected, definitions, and expected complication rates
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