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10.1186/s12890-017-0403-9 http://scihub22266oqcxt.onion/10.1186/s12890-017-0403-9 C5387322!5387322 !28399830     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=28399830 &cmd=llinks): Failed to open stream: HTTP request failed! 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Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study |pdf=|usr=}}{{28399830 }} gab.com Text Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study JO: BMC Pulm Med http://www.kidney.de/pget.php?&tw=1&pmid=28399830 #FOAvip 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 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. 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015. Twit Text FOAVip Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study ????BMC Pulm Med http://www.kidney.de/pget.php?&tw=1&pmid=28399830 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=28399830 #FOAvip English Wikipedia <ref>{{Cite pmid|28399830 }}</ref> Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study #MMPMID28399830 Khandhar SJ ; Bowling MR ; Flandes J ; Gildea TR ; Hood KL ; Krimsky WS ; Minnich DJ ; Murgu SD ; Pritchett M ; Toloza EM ; Wahidi MM ; Wolvers JJ ; Folch EE BMC Pulm Med 2017[Apr]; 17 (1 ): 59 PMID28399830 show ga 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 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. 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015. |Adult [MESH] |Aged [MESH] |Aged, 80 and over [MESH] |Bronchoscopy/*methods [MESH] |Diagnosis, Differential [MESH] |Electromagnetic Phenomena [MESH] |Europe [MESH] |Female [MESH] |Humans [MESH] |Image-Guided Biopsy/methods [MESH] |Lung Neoplasms/*diagnosis [MESH] |Lung/*pathology [MESH] |Lymph Nodes/pathology [MESH] |Male [MESH] |Middle Aged [MESH] |Neoplasm Staging [MESH] |Pneumothorax/epidemiology/etiology [MESH] |Prospective Studies [MESH] |Tomography, X-Ray Computed [MESH] |United States [MESH]Electromagnetic navigation bronchoscopy to access lung lesions in 1,00(epmc).pdf DeepDyve Pubget Overpricing