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

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02410837
• Collaborator: (none)
• Enrollment: 1,388
• Locations: 37
• Actual Duration (Months): 54.5
• Patients Per Site: 37.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Lesion(s) Requiring Evaluation	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1388 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
• Actual Study Start Date: Apr 16, 2015
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Outcome Measures

Primary Outcome Measures

1. Incidence of Pneumothorax (Grade 2+) [index procedure visit]

   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

Secondary Outcome Measures

1. Incidence of Pneumothorax (All) [index procedure visit]

   The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.

2. Incidence of Bronchopulmonary Hemorrhage [index procedure visit]

   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

3. Incidence of Respiratory Failure [index procedure visit]

   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

4. Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) [Baseline, 1 month, 12 month, and 24 month follow up visits]

   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.

5. Subject Satisfaction [at the 1 month follow up visit]

   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

6. Subject Productivity and Activity [at the 1 month follow up visit]

   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).

7. Diagnostic Yield [up to 24 months]

   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).

8. Sensitivity [up to 24 months]

   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])

9. Specificity [up to 24 months]

   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])

10. Positive Predictive Value [up to 24 months]

    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])

11. Negative Predictive Value [up to 24 months]

    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])

12. Repeat Biopsy Rate [up to 24 months]

    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.

13. Tissue Adequacy for Molecular Genetic Testing [at index procedure visit]

    Tissue adequacy for molecular genetic testing (if applicable).

14. Diagnosis [up to 24 months]

    Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)

15. Stage at Diagnosis [up to 24 months]

    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

16. Success Rate of Accurate Placement of Fiducial Markers [at index procedure visit]

    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.

17. Success Rate of Dye Marking [at index procedure visit]

    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.

18. Success Rate of Obtaining Lymph Node Biopsy [at index procedure visit]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Pulmonary Associates of Mobile, P.C.	Mobile	Alabama	United States	35294
3	Palo Alto Medical Foundation	Mountain View	California	United States	94040
4	Pulmonary and Sleep of Tampa Bay	Brandon	Florida	United States	33511
5	Ocala Lung and Critical Care	Ocala	Florida	United States	34471
6	Cancer Treatment Centers of America	Newnan	Georgia	United States	30265
7	The University of Chicago	Chicago	Illinois	United States	60637
8	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland	United States	21237
9	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109
10	Virtua Medical Group, PA	Marlton	New Jersey	United States	08053
11	University of Rochester	Rochester	New York	United States	14627
12	Carolina's Healthcare System	Charlotte	North Carolina	United States	28207
13	Duke University	Durham	North Carolina	United States	27705
14	East Carolina University	Greenville	North Carolina	United States	27834
15	Pinehurst Medical Center	Pinehurst	North Carolina	United States	28374
16	University of Cincinnati Physicians Company LLC	Cincinnati	Ohio	United States	45206
17	University Hospitals of Case Medical Center	Cleveland	Ohio	United States	44106
18	Cleveland Clinic	Cleveland	Ohio	United States	44195
19	Penn Highlands Healthcare	DuBois	Pennsylvania	United States	15801
20	UPMC - Shadyside Medical Center	Pittsburgh	Pennsylvania	United States	15232
21	Pulmonary Medicine Center of Chattanooga - Memorial Health	Chattanooga	Tennessee	United States	37404
22	Blount Memorial Hospital	Maryville	Tennessee	United States	37804
23	Vanderbilt University	Nashville	Tennessee	United States	37235
24	Seton Medical Center Austin	Austin	Texas	United States	78701
25	East Texas Medical Center	Tyler	Texas	United States	75701
26	Providence Health Center	Waco	Texas	United States	76712
27	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
28	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
29	Gundersen Lutheran Medical Foundation, Inc	La Crosse	Wisconsin	United States	54601
30	AKH Linz	Linz		Austria	4020
31	Salzburger Landesklinik (SALK)	Salzburg		Austria
32	Rigshospitalet - Copenhagen	Kobenhavn		Denmark
33	University Hospitals of Saint Etienne France	St. Etienne		France
34	Azienda Ospedaliero Universitaria Careggi	Firenze		Italy
35	IRCCS Azienda Ospedaliera Universitaria San Martino - IST	Genova		Italy	16132
36	Hospital Fundacion Jimenez Diaz	Madrid		Spain
37	St. Bartholomew's Hospital	London		United Kingdom

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Sandeep Khandhar, MD, Inova Fairfax Hospital
• Principal Investigator: Erik Folch, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 17, 2015

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02410837
• Other Study ID Numbers: COVENBP0475
• First Posted: Apr 8, 2015
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• Keywords provided by Medtronic - MITG: lung lesion; biopsy; bronchoscopy

Study Results

Participant Flow

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Period Title: Overall Study
STARTED	1388
Procedure	1388
1-Month	1374
12-Month	1121
24-Month	900
COMPLETED	900
NOT COMPLETED	488

Baseline Characteristics

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Overall Participants	1388
Overall Number of Lesions for Biopsy	1529
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	494 35.6%
>=65 years	894 64.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.6 (11.2)
Sex: Female, Male (Count of Participants)
Female	698 50.3%
Male	690 49.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	95 6.8%
Not Hispanic or Latino	1268 91.4%
Unknown or Not Reported	25 1.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	4 0.3%
Asian	8 0.6%
Native Hawaiian or Other Pacific Islander	1 0.1%
Black or African American	164 11.8%
White	1162 83.7%
Other	2 0.1%
Unknown	10 0.7%
Unable to report	37 2.7%
Region of Enrollment (participants) [Number]
Austria	20 1.4%
United States	1213 87.4%
Denmark	24 1.7%
Italy	36 2.6%
United Kingdom	42 3%
France	3 0.2%
Spain	50 3.6%
Tobacco history (current or former) (Count of Participants)
Count of Participants [Participants]	1107 79.8%
Chronic obstructive pulmonary disease (Count of Participants)
Count of Participants [Participants]	601 43.3%
Personal history of cancer (Count of Participants)
Count of Participants [Participants]	667 48.1%
Family history of cancer (Count of Participants)
Count of Participants [Participants]	816 58.8%
General anesthesia (Count of Participants)
Count of Participants [Participants]	1086 78.2%
Radial Endobronchial Ultrasound (R-EBUS) used during Electromagnetic Navigation Bronchoscopy (ENB) (Count of Participants)
Count of Participants [Participants]	703 50.6%
Cone-beam Computed Tomography (CBCT) used during ENB (Count of Participants)
Count of Participants [Participants]	77 5.5%
Fluoroscopy used during ENB (number of lesions) [Number]
Number [number of lesions]	1299
Rapid on-site evaluation (ROSE) used (Count of Participants)
Count of Participants [Participants]	777 56%
Average number of lesions biopsied per subject (Number of lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of lesions]	1.2 (0.4)
Lesion size (mm) (millimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millimeters]	20.0
Upper lobe lesion location (number of lesions) [Number]
Number [number of lesions]	897
Peripheral third of the lung (number of lesions) [Number]
Number [number of lesions]	1036
Lesion distance to pleura (mm) (millimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millimeters]	9.0
Pure to mostly ground glass opacity (GGO) lesions (Suzuki Class 1 or 2) (participants) [Number]
Number [participants]	95 6.8%
Spiculated lesion border (participants) [Number]
Number [participants]	923 66.5%
Bronchus sign present on Computed Tomography (CT) (participants) [Number]
Number [participants]	777 56%
Pre-test probability of malignancy >65% (Physician Estimate) (number of lesions) [Number]
Number [number of lesions]	730

Outcome Measures

1. Primary Outcome

Title	Incidence of Pneumothorax (Grade 2+)
Description	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
Time Frame	index procedure visit

Outcome Measure Data

Analysis Population Description

All subjects included in this analysis

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1388
Count of Participants [Participants]	44 3.2%

2. Secondary Outcome

Title	Incidence of Pneumothorax (All)
Description	The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.
Time Frame	index procedure visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1388
Count of Participants [Participants]	65 4.7%

3. Secondary Outcome

Title	Incidence of Bronchopulmonary Hemorrhage
Description	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
Time Frame	index procedure visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1388
Count of Participants [Participants]	23 1.7%

4. Secondary Outcome

Title	Incidence of Respiratory Failure
Description	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
Time Frame	index procedure visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1388
Count of Participants [Participants]	8 0.6%

5. Secondary Outcome

Title	Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)
Description	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.
Time Frame	Baseline, 1 month, 12 month, and 24 month follow up visits

Outcome Measure Data

Analysis Population Description

Number of subjects who completed the EQ-5D at the baseline visit.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1364
Baseline	70.2 (19.4)
1-Month	69.2 (20.4)
12-Month	70.0 (20.6)
24-Month	72.6 (18.7)

6. Secondary Outcome

Title	Subject Satisfaction
Description	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
Time Frame	at the 1 month follow up visit

Outcome Measure Data

Analysis Population Description

Subjects who completed the 1-month subject satisfaction questionnaire (How satisfied are you with ENB on a scale of 1-5)

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1227
Mean (Standard Deviation) [score on a scale]	4.4 (0.8)

7. Secondary Outcome

Title	Subject Productivity and Activity
Description	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).
Time Frame	at the 1 month follow up visit

Outcome Measure Data

Analysis Population Description

Number of subjects who completed the ENB-PAQ at 1-month

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	854
Mean (Standard Deviation) [score on a scale]	0.9 (2.1)

8. Secondary Outcome

Title	Diagnostic Yield
Description	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).
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Per subject including all those with attempted lung lesion biopsies. This includes any with unsuccessful navigation, but excludes subjects with insufficient follow-up where True Positive, True Negative, False Positive and False Negative could not be determined by 24 months.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1212
Count of Participants [Participants]	822 59.2%

9. Secondary Outcome

Title	Sensitivity
Description	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])
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects with a True Positive (TP) for Malignancy or False Negative (FN) for Malignancy diagnosis by 24-months.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	858
Count of Participants [Participants]	537 38.7%

10. Secondary Outcome

Title	Specificity
Description	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])
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects with a False Positive (FP) for Malignancy or True Negative (TN) for Malignancy diagnosis by 24-months.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	285
Count of Participants [Participants]	285 20.5%

11. Secondary Outcome

Title	Positive Predictive Value
Description	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])
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects with a True Positive (TP) for Malignancy or False Positive (FP) for Malignancy diagnosis by 24-months.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	537
Count of Participants [Participants]	537 38.7%

12. Secondary Outcome

Title	Negative Predictive Value
Description	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])
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects with a False Negative (FN) for Malignancy or True Negative (TN) for Malignancy diagnosis by 24-months.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	606
Count of Participants [Participants]	285 20.5%

13. Secondary Outcome

Title	Repeat Biopsy Rate
Description	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.
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects with navigation complete and tissue obtained

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1260
Count of Participants [Participants]	334 24.1%

14. Secondary Outcome

Title	Tissue Adequacy for Molecular Genetic Testing
Description	Tissue adequacy for molecular genetic testing (if applicable).
Time Frame	at index procedure visit

Outcome Measure Data

Analysis Population Description

This is the number of lesions diagnosed with primary lung adenocarcinoma or non-small-cell lung cancer not otherwise specified, where molecular genetic testing was attempted. This does not include all lesions biopsied as not all lesions had one of these specific diagnoses, nor did all these with these specific diagnoses have molecular testing attempted.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	102
Measure Lesions	110
Count of Units [Lesions]	89

15. Secondary Outcome

Title	Diagnosis
Description	Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects where navigation was complete and tissue was obtained for a diagnosis. Subjects with multiple lesion diagnoses may be represented more than once in all subcategories.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	1260
Measure Diagnoses	1276
Adenocarcinoma	279
Squamous Carcinoma	133
Other Non-small cell lung cancer	16
Small cell carcinoma	26
Neuroendocrine Carcinoma	17
Metastatic Carcinoma	49
Lymphoma	2
Malignant Cells (unable to characterize)	12
Malignant Atypical Cells	3
Other Malignancy	3
Benign Inflammation	198
Benign Other	97
Inconclusive	201
Normal Lung Tissue	119
Hamartoma	1
Granuloma	20
Bacterial Infection	24
Fungal Infection	14
Viral Infection	3
Organizing Pneumonia	7
Interstitial Lung Disease	7
Lymphocytes	10
Benign Atypical Cells	20
Other Benign	15

16. Secondary Outcome

Title	Stage at Diagnosis
Description	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
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

Number of subjects diagnosed with primary lung cancer.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	468
Stage I	251 18.1%
Stage II	52 3.7%
Stage III	81 5.8%
Stage IV	84 6.1%

17. Secondary Outcome

Title	Success Rate of Accurate Placement of Fiducial Markers
Description	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.
Time Frame	at index procedure visit

Outcome Measure Data

Analysis Population Description

Number of subjects where ENB was used to aid in placement of fiducial markers, and follow-up imaging data was available.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	269
Count of Participants [Participants]	253 18.2%

18. Secondary Outcome

Title	Success Rate of Dye Marking
Description	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.
Time Frame	at index procedure visit

Outcome Measure Data

Analysis Population Description

Number of subjects where ENB was used to aid in pleural dye marking.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	23
Count of Participants [Participants]	21 1.5%

19. Secondary Outcome

Title	Success Rate of Obtaining Lymph Node Biopsy
Description	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.
Time Frame	at index procedure visit

Outcome Measure Data

Analysis Population Description

Number of subjects where ENB was used to aid in lymph node biopsy.

Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
Measure Participants	36
Count of Participants [Participants]	31 2.2%

Adverse Events

Time Frame	Up to 24 months post procedure
Adverse Event Reporting Description	ISO 14155 event definitions were used. The following AEs were required to be reported: All AEs related to the superDimension™ navigation system, associated tools, or ENB™ procedure (both index and any subsequent repeat ENB™ procedure); All deaths (all-cause); All pneumothoraces (all-cause); All bronchopulmonary hemorrhages (all-cause); All respiratory failures (all cause) Important note: not all events reported in the study were related to the study procedure or study device.
Arm/Group Title	NAVIGATE (Single Arm Study)
Arm/Group Description	Observational NAVIGATE arm (single arm study, no comparator)
All Cause Mortality
	NAVIGATE (Single Arm Study)
	Affected / at Risk (%)	# Events
Total	403/1388 (29%)
Serious Adverse Events
	NAVIGATE (Single Arm Study)
	Affected / at Risk (%)	# Events
Total	497/1388 (35.8%)
Blood and lymphatic system disorders
Thrombocytopenia	1/1388 (0.1%)	1
Cardiac disorders
Acute myocardial infarction	1/1388 (0.1%)	1
Cardiac arrest	9/1388 (0.6%)	9
Cardiac failure	1/1388 (0.1%)	1
Cardiac failure congestive	3/1388 (0.2%)	3
Cardio-respiratory arrest	16/1388 (1.2%)	16
Cardiopulmonary failure	3/1388 (0.2%)	3
Cor pulmonale acute	1/1388 (0.1%)	1
Left ventricular failure	3/1388 (0.2%)	3
Myocardial infarction	2/1388 (0.1%)	2
Gastrointestinal disorders
Gastrointestinal haemorrhage	2/1388 (0.1%)	2
Inguinal hernia	1/1388 (0.1%)	1
Intestinal infarction	1/1388 (0.1%)	1
Intestinal perforation	1/1388 (0.1%)	1
Pancreatitis	1/1388 (0.1%)	1
General disorders
Death	86/1388 (6.2%)	86
Disease progression	2/1388 (0.1%)	2
Multiple organ dysfunction syndrome	1/1388 (0.1%)	1
Hepatobiliary disorders
Acute hepatic failure	1/1388 (0.1%)	1
Cirrhosis alcoholic	1/1388 (0.1%)	1
Hepatorenal syndrome	1/1388 (0.1%)	1
Infections and infestations
Bacteraemia	1/1388 (0.1%)	1
Bacterial sepsis	1/1388 (0.1%)	1
Lower respiratory tract infection	1/1388 (0.1%)	1
Pneumonia	7/1388 (0.5%)	7
Pneumonia fungal	1/1388 (0.1%)	1
Sepsis	5/1388 (0.4%)	5
Septic shock	2/1388 (0.1%)	2
Transmission of an infectious agent via product	1/1388 (0.1%)	1
Injury, poisoning and procedural complications
Gun shot wound	1/1388 (0.1%)	1
Post procedural haemorrhage	1/1388 (0.1%)	1
Procedural pneumothorax	3/1388 (0.2%)	3
Metabolism and nutrition disorders
Failure to thrive	1/1388 (0.1%)	1
Hyperglycaemia	1/1388 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/1388 (0.1%)	1
Adenocarcinoma	1/1388 (0.1%)	1
Adenocarcinoma of colon	1/1388 (0.1%)	1
Adenocarcinoma pancreas	1/1388 (0.1%)	1
Brain neoplasm malignant	2/1388 (0.1%)	2
Breast cancer	1/1388 (0.1%)	1
Breast cancer metastatic	4/1388 (0.3%)	4
Breast cancer stage IV	1/1388 (0.1%)	1
Bronchial carcinoma	1/1388 (0.1%)	1
Cervix carcinoma	1/1388 (0.1%)	1
Colon cancer	2/1388 (0.1%)	2
Diffuse large B-cell lymphoma	1/1388 (0.1%)	1
Extranodal marginal zone B-cell lymphoma (MALT type)	1/1388 (0.1%)	1
Invasive ductal breast carcinoma	1/1388 (0.1%)	1
Leiomyosarcoma metastatic	1/1388 (0.1%)	1
Lung adenocarcinoma	18/1388 (1.3%)	18
Lung cancer metastatic	23/1388 (1.7%)	23
Lung carcinoma cell type unspecified stage III	1/1388 (0.1%)	1
Lung carcinoma cell type unspecified stage IV	4/1388 (0.3%)	4
Lung neoplasm malignant	45/1388 (3.2%)	45
Lung squamous cell carcinoma metastatic	2/1388 (0.1%)	2
Lung squamous cell carcinoma stage IV	1/1388 (0.1%)	1
Lymphoma	1/1388 (0.1%)	1
Malignant neoplasm progression	1/1388 (0.1%)	1
Meningioma malignant	1/1388 (0.1%)	1
Metastases to central nervous system	2/1388 (0.1%)	2
Metastatic pulmonary embolism	1/1388 (0.1%)	1
Metastatic renal cell carcinoma	2/1388 (0.1%)	2
Metastatic uterine cancer	1/1388 (0.1%)	1
Neoplasm malignant	1/1388 (0.1%)	1
Neoplasm progression	3/1388 (0.2%)	3
Non-small cell lung cancer	3/1388 (0.2%)	3
Non-small cell lung cancer metastatic	2/1388 (0.1%)	2
Oesophageal adenocarcinoma	1/1388 (0.1%)	1
Oesophageal cancer metastatic	1/1388 (0.1%)	1
Pancreatic carcinoma	4/1388 (0.3%)	4
Pancreatic carcinoma metastatic	1/1388 (0.1%)	1
Pharyngeal cancer	1/1388 (0.1%)	1
Prostate cancer	2/1388 (0.1%)	2
Rectal cancer	2/1388 (0.1%)	2
Renal cancer metastatic	1/1388 (0.1%)	1
Renal cell carcinoma	2/1388 (0.1%)	2
Small cell lung cancer	1/1388 (0.1%)	1
Small cell lung cancer metastatic	1/1388 (0.1%)	1
Squamous cell carcinoma	3/1388 (0.2%)	3
Squamous cell carcinoma of lung	5/1388 (0.4%)	5
Transitional cell carcinoma	1/1388 (0.1%)	1
Uterine leiomyosarcoma	1/1388 (0.1%)	1
Nervous system disorders
Cerebral infarction	1/1388 (0.1%)	1
Cerebrovascular accident	4/1388 (0.3%)	4
Renal and urinary disorders
Goodpasture's syndrome	1/1388 (0.1%)	1
Renal failure	1/1388 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	8/1388 (0.6%)	8
Apnoea	1/1388 (0.1%)	1
Bronchial obstruction	1/1388 (0.1%)	1
Chronic obstructive pulmonary disease	3/1388 (0.2%)	3
Haemoptysis	1/1388 (0.1%)	1
Hypoxia	2/1388 (0.1%)	2
Interstitial lung disease	1/1388 (0.1%)	1
Lung disorder	1/1388 (0.1%)	1
Mediastinal haematoma	1/1388 (0.1%)	2
Organising pneumonia	1/1388 (0.1%)	1
Pneumomediastinum	2/1388 (0.1%)	2
Pneumonia aspiration	1/1388 (0.1%)	1
Pneumothorax	81/1388 (5.8%)	83
Pulmonary embolism	2/1388 (0.1%)	2
Pulmonary haemorrhage	15/1388 (1.1%)	15
Respiratory failure	111/1388 (8%)	138
Vascular disorders
Arteriosclerosis	1/1388 (0.1%)	1
Arteriovenous fistula	1/1388 (0.1%)	1
Peripheral circulatory failure	1/1388 (0.1%)	1
Other (Not Including Serious) Adverse Events
	NAVIGATE (Single Arm Study)
	Affected / at Risk (%)	# Events
Total	96/1388 (6.9%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	72/1388 (5.2%)	73
Pulmonary haemorrhage	24/1388 (1.7%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Institution and Investigator shall not publish the Study results until after Sponsor's multi-site publication of complete and final study results or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs earlier; unless approved by Sponsor.