NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
NCT ID: NCT02410837
Last Updated: 2021-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
1388 participants
OBSERVATIONAL
2015-04-16
2019-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Electromagnetic Navigation Bronchoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to provide informed consent to participate in the study
* Subject is candidate for elective ENB™ procedure
* Subject is over the age of 18
Exclusion Criteria
* The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
* Female subjects who are pregnant or nursing as determined by standard site practices
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Sandeep Khandhar, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Fairfax Hospital
Erik Folch, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
Palo Alto Medical Foundation
Mountain View, California, United States
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, United States
Ocala Lung and Critical Care
Ocala, Florida, United States
Cancer Treatment Centers of America
Newnan, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Virtua Medical Group, PA
Marlton, New Jersey, United States
University of Rochester
Rochester, New York, United States
Carolina's Healthcare System
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Pinehurst Medical Center
Pinehurst, North Carolina, United States
University of Cincinnati Physicians Company LLC
Cincinnati, Ohio, United States
University Hospitals of Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Penn Highlands Healthcare
DuBois, Pennsylvania, United States
UPMC - Shadyside Medical Center
Pittsburgh, Pennsylvania, United States
Pulmonary Medicine Center of Chattanooga - Memorial Health
Chattanooga, Tennessee, United States
Blount Memorial Hospital
Maryville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Seton Medical Center Austin
Austin, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
Providence Health Center
Waco, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Gundersen Lutheran Medical Foundation, Inc
La Crosse, Wisconsin, United States
AKH Linz
Linz, , Austria
Salzburger Landesklinik (SALK)
Salzburg, , Austria
Rigshospitalet - Copenhagen
Copenhagen, , Denmark
University Hospitals of Saint Etienne France
Saint-Etienne, , France
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST
Genova, , Italy
Hospital Fundacion Jimenez Diaz
Madrid, , Spain
St. Bartholomew's Hospital
London, , United Kingdom
Countries
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References
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Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.
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; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.
Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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COVENBP0475
Identifier Type: -
Identifier Source: org_study_id
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