Evidence map›Paper›PMID 28399830›Full record

ArticleBMC pulmonary medicine2017

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

Sandeep J Khandhar, Mark R Bowling, Javier Flandes, Thomas R Gildea, Kristin L Hood, William S Krimsky, Douglas J Minnich, Septimiu D Murgu, Michael Pritchett, Eric M Toloza and 4 more

3 registry-linked trialsAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pulmonary medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02410837 completednot on this map

NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

Typeobservational_patient_registrySponsorMedtronic - MITGRan2015 to 2019Enrolled1,388ConditionsLung Lesion(s) Requiring EvaluationArmsElectromagnetic Navigation Bronchoscopy
NCT03716284 completednot on this mapstarted 2019, after this paper: background citation

Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study

TypeobservationalSponsorShanghai Chest HospitalRan2019 to 2022Enrolled479ConditionsPeripheral Pulmonary NodulesArmsElectromagnetic navigation bronchoscopy (ENB)
NCT04758403 naterminatednot on this mapstarted 2021, after this paper: background citation

Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2021 to 2023Enrolled20ConditionsPeripheral Pulmonary Nodules, Lung, Node, Cone Beam Computed TomographyArmsNavigation Bronchoscopy, Cone beam computed tomography (CBCT)
3 · Its place in the literature

Who cites it

55 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Sandeep J KhandharInova Health System, Fairfax Hospital, Falls Church, VA, USA.
Mark R BowlingEast Carolina University, Greenville, NC, USA.
Javier FlandesPulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Madrid, Spain.
Thomas R GildeaDepartment of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, OH, USA.
Kristin L HoodMedtronic, Minneapolis, MN, USA.
William S KrimskyPulmonary and Critical Care Associates of Baltimore, Baltimore, MD, USA.
Douglas J MinnichDivision of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
Septimiu D MurguInterventional Pulmonology Fellowship Program, The University of Chicago Medicine, Chicago, IL, USA.
Michael PritchettPulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, NC, USA.
Eric M TolozaDepartment of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Momen M WahidiDepartment of Medicine, Duke University Medical Center, Durham, NC, USA.
Jennifer J WolversMedtronic, Minneapolis, MN, USA.
Erik E FolchDivision of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Bulfinch 148, Boston, MA, 02114, USA. efolch@mgh.harvard.edu.
NAVIGATE Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.

methodsNAVIGATE 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.

resultsENB 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.

conclusionsOne-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 registrationClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Indexed as

AdultAgedAged, 80 and overBronchoscopyDiagnosis, DifferentialElectromagnetic PhenomenaEuropeFemaleHumansImage-Guided BiopsyLungLung NeoplasmsLymph NodesMaleMiddle AgedNeoplasm StagingImage-Guided BiopsyLung CancerLung NeoplasmsNeoplasm StagingSolitary Pulmonary Nodule

Identifiers

PMID28399830
PMCPMC5387322

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.