Clinical trial NCT02410837: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Official title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Lesion(s) Requiring Evaluation
Keywords: lung lesion
biopsy
bronchoscopy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 1388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.

Brief summary: The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility criteria: Inclusion Criteria:

* Subject presents with lung lesion(s) requiring evaluation
* 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 is unable or unwilling to comply with study follow-up schedule
* 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

Primary outcomes:
measure: Incidence of Pneumothorax (Grade 2+)
timeFrame: index procedure visit
Secondary outcomes:
measure: Incidence of Pneumothorax (All)
timeFrame: index procedure visit
measure: Incidence of Bronchopulmonary Hemorrhage
timeFrame: index procedure visit
measure: Incidence of Respiratory Failure
timeFrame: index procedure visit
measure: Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)
timeFrame: Baseline, 1 month, 12 month, and 24 month follow up visits
measure: Subject Satisfaction
timeFrame: at the 1 month follow up visit
measure: Subject Productivity and Activity
timeFrame: at the 1 month follow up visit
measure: Diagnostic Yield
timeFrame: up to 24 months
measure: Sensitivity
timeFrame: up to 24 months
measure: Specificity
timeFrame: up to 24 months
measure: Positive Predictive Value
timeFrame: up to 24 months
measure: Negative Predictive Value
timeFrame: up to 24 months
measure: Repeat Biopsy Rate
timeFrame: up to 24 months
measure: Tissue Adequacy for Molecular Genetic Testing
timeFrame: at index procedure visit
measure: Diagnosis
timeFrame: up to 24 months
measure: Stage at Diagnosis
timeFrame: up to 24 months
measure: Success Rate of Accurate Placement of Fiducial Markers
timeFrame: at index procedure visit
measure: Success Rate of Dye Marking
timeFrame: at index procedure visit
measure: Success Rate of Obtaining Lymph Node Biopsy
timeFrame: at index procedure visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, P.C.
state: Alabama
city: Mountain View
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Brandon
country: United States
facility: Pulmonary and Sleep of Tampa Bay
state: Florida
city: Ocala
country: United States
facility: Ocala Lung and Critical Care
state: Florida
city: Newnan
country: United States
facility: Cancer Treatment Centers of America
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Marlton
country: United States
facility: Virtua Medical Group, PA
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Carolina's Healthcare System
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: DuBois
country: United States
facility: Penn Highlands Healthcare
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Shadyside Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Pulmonary Medicine Center of Chattanooga - Memorial Health
state: Tennessee
city: Maryville
country: United States
facility: Blount Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation, Inc
state: Wisconsin
city: Linz
country: Austria
facility: AKH Linz
city: Salzburg
country: Austria
facility: Salzburger Landesklinik (SALK)
city: Kobenhavn
country: Denmark
facility: Rigshospitalet - Copenhagen
city: St. Etienne
country: France
facility: University Hospitals of Saint Etienne France
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
affiliation: Inova Fairfax Hospital
name: Sandeep Khandhar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Erik Folch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.