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    Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study

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    10.1186-s12890-017-0403-9.pdf (718.7Kb)

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    Author
    Khandhar, Sandeep J.; Bowling, Mark R.; Flandes, Javier; Gildea, Thomas R.; Hood, Kristin L.; Krimsky, William S.; Minnich, Douglas J.; Murgu, Septimiu D.; Pritchett, Michael; Toloza, Eric M.; Wahidi, Momen M.; Wolvers, Jennifer J.; Folch, Erik E.; NAVIGATE Study Investigators
    Abstract
    Background: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. Methods: NAVIGATE is a prospective, multicenter study of the superDimensionTM 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. Results: 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. Conclusions: 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.
    URI
    http://hdl.handle.net/10342/8178
    Date
    2017-04
    Citation:
    APA:
    Khandhar, Sandeep J., & Bowling, Mark R., & Flandes, Javier, & Gildea, Thomas R., & Hood, Kristin L., & Krimsky, William S., & Minnich, Douglas J., & Murgu, Septimiu D., & Pritchett, Michael, & Toloza, Eric M., & Wahidi, Momen M., & Wolvers, Jennifer J., & Folch, Erik E., & NAVIGATE Study Investigators. (April 2017). Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. , (), - . Retrieved from http://hdl.handle.net/10342/8178

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    MLA:
    Khandhar, Sandeep J., and Bowling, Mark R., and Flandes, Javier, and Gildea, Thomas R., and Hood, Kristin L., and Krimsky, William S., and Minnich, Douglas J., and Murgu, Septimiu D., and Pritchett, Michael, and Toloza, Eric M., and Wahidi, Momen M., and Wolvers, Jennifer J., and Folch, Erik E., and NAVIGATE Study Investigators. "Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study". . . (), April 2017. December 11, 2023. http://hdl.handle.net/10342/8178.
    Chicago:
    Khandhar, Sandeep J. and Bowling, Mark R. and Flandes, Javier and Gildea, Thomas R. and Hood, Kristin L. and Krimsky, William S. and Minnich, Douglas J. and Murgu, Septimiu D. and Pritchett, Michael and Toloza, Eric M. and Wahidi, Momen M. and Wolvers, Jennifer J. and Folch, Erik E. and NAVIGATE Study Investigators, "Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study," , no. (April 2017), http://hdl.handle.net/10342/8178 (accessed December 11, 2023).
    AMA:
    Khandhar, Sandeep J., Bowling, Mark R., Flandes, Javier, Gildea, Thomas R., Hood, Kristin L., Krimsky, William S., Minnich, Douglas J., Murgu, Septimiu D., Pritchett, Michael, Toloza, Eric M., Wahidi, Momen M., Wolvers, Jennifer J., Folch, Erik E., NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. . April 2017; (): . http://hdl.handle.net/10342/8178. Accessed December 11, 2023.
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