TY - JOUR
T1 - Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy
AU - Folch, Erik E.
AU - Bowling, Mark R.
AU - Gildea, Thomas R.
AU - Hood, Kristin L.
AU - Murgu, Septimiu D.
AU - Toloza, Eric M.
AU - Wahidi, Momen M.
AU - Williams, Terence
AU - Khandhar, Sandeep J.
N1 - Funding Information:
Study sponsored and funded by Medtronic (Minneapolis, MN). Other competing interests related to the submitted work: EEF, MRB, TG, SDM, EMT, MMW, TW, and SJK serve on the Clinical Advisory Board for Medtronic and received travel funds and fees for participation; KH is a full-time employee of Medtronic; MMW received consulting fees from Medtronic; TW received speaker fees from Medtronic. Outside the submitted work: EEF is on the Scientific Advisory board for Boston Scientific and the Education Advisory Board for Olympus; MRB received consulting fees from Medtronic; EMT received travel funds and honoraria from Medtronic as a member of their Speakers’ Bureau; TW received a research grant form Veran Medical Systems.
Publisher Copyright:
© 2016 Folch et al.
PY - 2016/4/26
Y1 - 2016/4/26
N2 - 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 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 24months 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.
AB - 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 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 24months 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.
KW - Bronchoscopy
KW - Electromagnetic navigation
KW - Image-guided biopsy
KW - Lung cancer
KW - Lung neoplasms
KW - Neoplasm staging
KW - Solitary pulmonary nodule
KW - SuperDimension
UR - http://www.scopus.com/inward/record.url?scp=84964317383&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84964317383&partnerID=8YFLogxK
U2 - 10.1186/s12890-016-0228-y
DO - 10.1186/s12890-016-0228-y
M3 - Article
C2 - 27113209
AN - SCOPUS:84964317383
SN - 1471-2466
VL - 16
JO - BMC Pulmonary Medicine
JF - BMC Pulmonary Medicine
IS - 1
M1 - 60
ER -
