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

Abstract

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.

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

“…Not applicable to patients with a diagnosis of cancer that has been made within the previous 5 years or to patients with previous lung cancer [29] b See Folch et al 2016 for definitions [7]…”

The introduction of electromagnetic navigation bronchoscopy for the diagnosis of small pulmonary peripheral lesions in an Asian population

“…This new technology has been successfully used on animal models since 2003; the first human study was performed in 2005; and to date, over 20,000 procedures have been performed (4,11). During the procedure, ENB-aided diagnostics yielded approximately 75% accuracy and the occurrence of pneumothorax was less than 5% in most studies (12). Thus far, it has become a most suitable assessment tool for SPPLs.…”

“…To answer this question, we designed this study following previously reported instructions (12). Three physicians from our hospital have been using ENB since 2013.…”

Pleural dye marking of lung nodules by electromagnetic navigation bronchoscopy

“…NAVIGATE (http://www.clinicaltrials.gov, NCT02410837) is a prospective, multicentre, global, and single‐arm cohort study evaluating ENB procedures . All ENB procedures used the superDimension navigation system version 6.0 or higher (Medtronic, Minneapolis, MN).…”