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

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

Study Overview

• Status: Completed
• Conditions: Lung Lesion(s) Requiring Evaluation
• Intervention / Treatment: Procedure: Electromagnetic Navigation Bronchoscopy

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.)

• Study Type: Observational
• Enrollment (Actual): 1388

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • AKH Linz
  • Salzburg, Austria
    • Salzburger Landesklinik (SALK)
• Denmark
  • Kobenhavn, Denmark
    • Rigshospitalet - Copenhagen
• France
  • St. Etienne, France
    • University Hospitals of Saint Etienne France
• Italy
  • Firenze, Italy
    • Azienda Ospedaliero Universitaria Careggi
  • Genova, Italy, 16132
    • IRCCS Azienda Ospedaliera Universitaria San Martino - IST
• Spain
  • Madrid, Spain
    • Hospital Fundación Jiménez Díaz
• United Kingdom
  • London, United Kingdom
    • St. Bartholomew's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama At Birmingham
    • Mobile, Alabama, United States, 35294
      • Pulmonary Associates of Mobile, P.C.
  • California
    • Mountain View, California, United States, 94040
      • Palo Alto Medical Foundation
  • Florida
    • Brandon, Florida, United States, 33511
      • Pulmonary and Sleep of Tampa Bay
    • Ocala, Florida, United States, 34471
      • Ocala Lung and Critical Care
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Pulmonary and Critical Care Associates of Baltimore
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Systems
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Medical Group, PA
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Carolina's Healthcare System
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • University of Cincinnati Physicians Company LLC
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Case Medical Center
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Penn Highlands Healthcare
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC - Shadyside Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Pulmonary Medicine Center of Chattanooga - Memorial Health
    • Maryville, Tennessee, United States, 37804
      • Blount Memorial Hospital
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University
  • Texas
    • Austin, Texas, United States, 78701
      • Seton Medical Center Austin
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
    • Waco, Texas, United States, 76712
      • Providence Health Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pneumothorax (Grade 2+)	The primary endpoint is the incidence of pneumothorax related to the ENB™ index procedure rated as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) scale. Pneumothorax is a disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung. Severity increases as grade increases. Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis); Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death	index procedure visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pneumothorax (All)	The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.	index procedure visit
Incidence of Bronchopulmonary Hemorrhage	The incidence of bronchopulmonary hemorrhage (rated as Grade 2 or higher according to th CTCAE scale) related to all ENB™ index procedures will be evaluated. Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. Severity increases as grade increases. Grade 1: Mild symptoms; intervention not indicated; Grade 2: Moderate symptoms; medical intervention indicated; Grade 3: Transfusion, radiologic, endoscopic, or operative intervention indicated (e.g., hemostasis of bleeding site); Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated; Grade 5: Death	index procedure visit
Incidence of Respiratory Failure	The incidence of respiratory failure (rated as Grade 4 or higher according to the CTCAE scale) related to all ENB™ index procedures will be evaluated. A respiratory failure is a disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxemia and a decrease in oxygenation of the tissues that may be associated with an increase in arterial levels of carbon dioxide. Severity increases as grade increases. Within CTCAE, there are no grades 1, 2, or 3 for Respiratory Failure. Grade 4: Life-threatening consequences; urgent intervention, intubation, or ventilatory support indicated; Grade 5: Death	index procedure visit
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)	Subject health status evaluated by EuroQol-5d (EQ-5D) questionnaire at all visits. (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health state) Questionnaire from EuroQol Group. Outcome reported on overall health state over time. 0 = worst imaginable health state, 100 = best imaginable health state.	Baseline, 1 month, 12 month, and 24 month follow up visits
Subject Satisfaction	Subject satisfaction evaluation at the 1 month visit. The question was "overall, how satisfied were you with the ENB procedure". Options were: Totally Dissatisfied; Dissatisfied; Neutral; Satisfied; Extremely Satisfied	at the 1 month follow up visit
Subject Productivity and Activity	Electromagnetic Navigation Bronchoscopy (ENB) procedure effect on subject productivity and activity using the ENB Productivity and Activity Questionnaire (ENB-PAQ) will be evaluated. The outcome measurement is the effect of ENB on their regular daily activities on a scale of 0-10 (0=no effect, 10=completely prevented).	at the 1 month follow up visit
Diagnostic Yield	Diagnostic yield will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion. Diagnostic yield was calculated per subject as the rate of true positives (TP) (for malignancy) plus true negatives (TN) (for malignancy) out of all subjects with attempted lung lesion biopsies (the denominator included subjects with no tissue obtained due to unsuccessful navigation).	up to 24 months
Sensitivity	Sensitivity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion. [True Positives =TP, False Negatives = FN]. (TP / [TP+FN])	up to 24 months
Specificity	Specificity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Positives = FN] (TN / [FP+TN])	up to 24 months
Positive Predictive Value	Positive predictive value (PPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Positives = TP, False Positives = FP] (TP / [TP+FP])	up to 24 months
Negative Predictive Value	Negative Predictive Value (NPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Negatives = FN] (TN / [FN+TN])	up to 24 months
Repeat Biopsy Rate	Repeat biopsy rate due to lack of diagnosis during the ENB™ index procedure will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion.	up to 24 months
Tissue Adequacy for Molecular Genetic Testing	Tissue adequacy for molecular genetic testing (if applicable).	at index procedure visit
Diagnosis	Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)	up to 24 months
Stage at Diagnosis	Stage at diagnosis (if applicable) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. (Diagnosis worsens as stage number increases). Refer to the American Joint Committee on Cancer, 7th edition on Lung Cancer Staging. A brief description is provided here. Stage I = small lesions, no lymph node involvement Stage II = larger lesions and/or lymph nodes on sides of lung involved Stage III = larger lesions and/or lymph nodes in middle of chest involved Stage IV = metastases to other organs	up to 24 months
Success Rate of Accurate Placement of Fiducial Markers	The success rate of accurate placement of fiducial markers demonstrated through follow up imaging will be evaluated for all ENB™ index procedures conducted for placement of fiducial markers.	at index procedure visit
Success Rate of Dye Marking	The success rate of dye marking demonstrated by successful surgical resection will be evaluated for all ENB™ index procedures conducted for dye marking in preparation for surgical resection.	at index procedure visit
Success Rate of Obtaining Lymph Node Biopsy	The success rate of obtaining a lymph node biopsy to provide the stage of diagnosis will be evaluated for all ENB™ index procedures conducted for a lymph node biopsy.	at index procedure visit

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Sandeep Khandhar, MD, Inova Fairfax Hospital; Principal Investigator: Erik Folch, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: bronchoscopy; biopsy; lung lesion
• Other Study ID Numbers: COVENBP0475