• Find People
  • Campus Map
  • PiratePort
  • A-Z
    • About
    • Submit
    • Browse
    • Login
    View Item 
    •   ScholarShip Home
    • Other Campus Research
    • Open Access
    • View Item
    •   ScholarShip Home
    • Other Campus Research
    • Open Access
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of The ScholarShipCommunities & CollectionsDateAuthorsTitlesSubjectsTypeDate SubmittedThis CollectionDateAuthorsTitlesSubjectsTypeDate Submitted

    My Account

    Login

    Statistics

    View Google Analytics Statistics

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

    Thumbnail
    View/ Open
    Folch2016_Article_DesignOfAProspectiveMulticente.pdf (460.7Kb)

    Show full item record
    
    Author
    Folch, Erik E.; Bowling, Mark R.; Gildea, Thomas R.; Hood, Kristin L.; Murgu, Septimiu D.; Toloza, Eric M.; Wahidi, Momen M.; Williams, Terence; Khandhar, Sandeep J.
    Abstract
    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 superDimensionTM 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. 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. Trial registration: ClinicalTrials.gov NCT02410837. Registered 31 March 2015. Keywords: Bronchoscopy, Electromagnetic navigation, Image-guided biopsy, Lung cancer, Lung neoplasms, Neoplasm staging, Solitary pulmonary nodule, superDimension
    URI
    http://hdl.handle.net/10342/8533
    Date
    2016-04-26
    Citation:
    APA:
    Folch, Erik E., & Bowling, Mark R., & Gildea, Thomas R., & Hood, Kristin L., & Murgu, Septimiu D., & Toloza, Eric M., & Wahidi, Momen M., & Williams, Terence, & Khandhar, Sandeep J.. (April 2016). Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulmonary Medicine, (16:1), p.. Retrieved from http://hdl.handle.net/10342/8533

    Display/Hide MLA, Chicago and APA citation formats.

    MLA:
    Folch, Erik E., and Bowling, Mark R., and Gildea, Thomas R., and Hood, Kristin L., and Murgu, Septimiu D., and Toloza, Eric M., and Wahidi, Momen M., and Williams, Terence, and Khandhar, Sandeep J.. "Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy". BMC Pulmonary Medicine. 16:1. (.), April 2016. August 16, 2022. http://hdl.handle.net/10342/8533.
    Chicago:
    Folch, Erik E. and Bowling, Mark R. and Gildea, Thomas R. and Hood, Kristin L. and Murgu, Septimiu D. and Toloza, Eric M. and Wahidi, Momen M. and Williams, Terence and Khandhar, Sandeep J., "Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy," BMC Pulmonary Medicine 16, no. 1 (April 2016), http://hdl.handle.net/10342/8533 (accessed August 16, 2022).
    AMA:
    Folch, Erik E., Bowling, Mark R., Gildea, Thomas R., Hood, Kristin L., Murgu, Septimiu D., Toloza, Eric M., Wahidi, Momen M., Williams, Terence, Khandhar, Sandeep J.. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulmonary Medicine. April 2016; 16(1) . http://hdl.handle.net/10342/8533. Accessed August 16, 2022.
    Collections
    • Open Access

    xmlui.ArtifactBrowser.ItemViewer.elsevier_entitlement

    East Carolina University has created ScholarShip, a digital archive for the scholarly output of the ECU community.

    • About
    • Contact Us
    • Send Feedback