Medtronic. Dr. Nead has received personal fees from Medtronic. Dr. Bowling has received personal fees from Medtronic. Dr. Murgu has received personal fees from Medtronic, Boston Scientific, Pinnacle Biologics, Olympus, Cook, Auris Robotics, and Elsevier; and has stock ownership in Concordia, Boston Scientific, and Merck. Dr. Krimsky has received personal fees from Medtronic, Innovital Systems, Gala Therapeutic, SOC, and Peytant; has stock ownership with Innovital Systems and CSA Medical; and has patents pending with Medtronic and Merit. Dr. Murillo has received support from Medtronic. Dr. LeMense has received personal fees from Medtronic. Dr. Minnich has received personal fees from Medtronic. Dr. Bansal has received personal fees from Medtronic, Pinnacle Biologics, Sunovion, and Veran Medical. Dr. Ellis has received support from Medtronic. Dr. Mahajan has received personal fees from Medtronic. Dr. Gildea has received personal fees from Medtronic. Dr. Bechara has received support from Medtronic. Dr. Sztejman has received support from Medtronic. Dr. Flandes has received grants from BTG-PneumRx and Ambu; and personal fees from Medtronic, BTG-PneumRx, Olympus, Ambu, PulmonX, and Boston Scientific. Dr. Rickman has received personal fees from Medtronic, Veran Medical, BD, Olympus, and Abbvie. Dr. Benzaquen has received support from Medtronic. Dr. Hogarth has received personal fees from Medtronic, Auris Surgical Robotics, Boston Scientific, Grifols, Shire, and CSL; and has stock ownership with Auris Surgical Robotics. Dr. Linden has received support from Medtronic. Dr. Wahidi has received personal fees from Medtronic and Veran Medical. Dr. Mattingley has received personal fees from Medtronic and is current employee of Medtronic (employment began after completion of enrollment). Dr. Hood is an employee with stock ownership at Medtronic; and has stock ownership with Boston Scientific. Ms. Lin and Ms. Wolvers are employees with stock ownership at Medtronic. Dr. Khandar has received personal fees from Medtronic.

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-017-0403-9) contains supplementary material, which is available to authorized users.

Navigational bronchoscopy is a safe and effective pulmonary diagnostic tool with relatively low complication rate. The diagnostic yield and overall success of the procedure does not seem to be affected by the type of sedation used.

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BackgroundElectromagnetic 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/DesignNAVIGATE (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.DiscussionStudy 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.Trial registrationClinicalTrials.gov NCT02410837. Registered 31 March 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-016-0228-y) contains supplementary material, which is available to authorized users.