Trial Outcomes & Findings for NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™ (NCT NCT02410837)

Last Updated: 2021-05-10

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

1388 participants

Primary outcome timeframe

index procedure visit

Results posted on

2021-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	NAVIGATE (Single Arm Study) Observational NAVIGATE arm (single arm study, no comparator)
Overall Study STARTED	1388
Overall Study Procedure	1388
Overall Study 1-Month	1374
Overall Study 12-Month	1121
Overall Study 24-Month	900
Overall Study COMPLETED	900
Overall Study NOT COMPLETED	488

Reasons for withdrawal

Reasons for withdrawal
Measure	NAVIGATE (Single Arm Study) Observational NAVIGATE arm (single arm study, no comparator)
Overall Study Death	387
Overall Study Lost to Follow-up	50
Overall Study Withdrawal by Subject	44
Overall Study Physician Decision	6
Overall Study Moved to nursing home, cannot communicat	1

Baseline Characteristics

Number of lesions (subjects could have more than one lesion)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAVIGATE (Single Arm Study) n=1529 Number of Lesions for Biopsy Observational NAVIGATE arm (single arm study, no comparator)
Age, Categorical <=18 years	0 Participants n=1388 Participants
Age, Categorical Between 18 and 65 years	494 Participants n=1388 Participants
Age, Categorical >=65 years	894 Participants n=1388 Participants
Age, Continuous	67.6 years STANDARD_DEVIATION 11.2 • n=1388 Participants
Sex: Female, Male Female	698 Participants n=1388 Participants
Sex: Female, Male Male	690 Participants n=1388 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	95 Participants n=1388 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1268 Participants n=1388 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=1388 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	4 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Asian	8 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	1 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Black or African American	164 Participants n=1388 Participants
Race/Ethnicity, Customized Race · White	1162 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Unknown	10 Participants n=1388 Participants
Race/Ethnicity, Customized Race · Unable to report	37 Participants n=1388 Participants
Region of Enrollment Austria	20 participants n=1388 Participants
Region of Enrollment United States	1213 participants n=1388 Participants
Region of Enrollment Denmark	24 participants n=1388 Participants
Region of Enrollment Italy	36 participants n=1388 Participants
Region of Enrollment United Kingdom	42 participants n=1388 Participants
Region of Enrollment France	3 participants n=1388 Participants
Region of Enrollment Spain	50 participants n=1388 Participants
Tobacco history (current or former)	1107 Participants n=1388 Participants
Chronic obstructive pulmonary disease	601 Participants n=1388 Participants
Personal history of cancer	667 Participants n=1388 Participants
Family history of cancer	816 Participants n=1388 Participants
General anesthesia	1086 Participants n=1388 Participants
Radial Endobronchial Ultrasound (R-EBUS) used during Electromagnetic Navigation Bronchoscopy (ENB)	703 Participants n=1388 Participants
Cone-beam Computed Tomography (CBCT) used during ENB	77 Participants n=1388 Participants
Fluoroscopy used during ENB	1299 number of lesions n=1529 Number of Lesions for Biopsy • Number of lesions (subjects could have more than one lesion)
Rapid on-site evaluation (ROSE) used	777 Participants n=1260 Participants • Number of subjects undergoing ENB for lesion biopsy where navigation was successful
Average number of lesions biopsied per subject	1.2 Number of lesions STANDARD_DEVIATION 0.4 • n=1329 Participants • 1329 subjects who underwent ENB for lung lesion biopsy
Lesion size (mm)	20.0 millimeters n=1529 Number of Lesions for Biopsy • Number of lesions where size was provided
Upper lobe lesion location	897 number of lesions n=1529 Number of Lesions for Biopsy • Number of lesions (subjects could have more than one lesion)
Peripheral third of the lung	1036 number of lesions n=1529 Number of Lesions for Biopsy • Number of lesions (subjects could have more than one lesion)
Lesion distance to pleura (mm)	9.0 millimeters n=1514 Number of Lesions for Biopsy • Number of lesions where distance was provided. 1514 lesions in 1317 subjects had "lesion distance to pleura" information.
Pure to mostly ground glass opacity (GGO) lesions (Suzuki Class 1 or 2)	95 participants n=1523 Number of Lesions for Biopsy • Number of lesions where ground glass was evaluated. 1523 lesions in 1323 subjects where ground glass opacity (GGO) was evaluated.
Spiculated lesion border	923 participants n=1527 Number of Lesions for Biopsy • Number of lesions where lesion border was evaluated and reported. 1527 lesions in 1328 subjects had lesion border information.
Bronchus sign present on Computed Tomography (CT)	777 participants n=1529 Number of Lesions for Biopsy • Number of lesions where bronchus sign presence was evaluated
Pre-test probability of malignancy >65% (Physician Estimate)	730 number of lesions n=1188 Number of Lesions for Biopsy • Number of lesions where the physicians estimate of pre-test probability of malignancy was evaluated

PRIMARY outcome

Timeframe: index procedure visit

Population: All subjects included in this analysis

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1388 Participants Observational NAVIGATE arm (single arm study, no comparator)
Incidence of Pneumothorax (Grade 2+)	44 Participants

SECONDARY outcome

Timeframe: index procedure visit

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

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1388 Participants Observational NAVIGATE arm (single arm study, no comparator)
Incidence of Pneumothorax (All)	65 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1388 Participants Observational NAVIGATE arm (single arm study, no comparator)
Incidence of Bronchopulmonary Hemorrhage	23 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1388 Participants Observational NAVIGATE arm (single arm study, no comparator)
Incidence of Respiratory Failure	8 Participants

SECONDARY outcome

Timeframe: Baseline, 1 month, 12 month, and 24 month follow up visits

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

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.

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1364 Participants Observational NAVIGATE arm (single arm study, no comparator)
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) Baseline	70.2 score on a scale Standard Deviation 19.4
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) 1-Month	69.2 score on a scale Standard Deviation 20.4
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) 12-Month	70.0 score on a scale Standard Deviation 20.6
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) 24-Month	72.6 score on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: at the 1 month follow up visit

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

Subject satisfaction evaluation at the 1 month visit. The question was "overall, how satisfied were you with the ENB procedure". Options were: 1. Totally Dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1227 Participants Observational NAVIGATE arm (single arm study, no comparator)
Subject Satisfaction	4.4 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: at the 1 month follow up visit

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

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).

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=854 Participants Observational NAVIGATE arm (single arm study, no comparator)
Subject Productivity and Activity	0.9 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: up to 24 months

Population: 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.

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).

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1212 Participants Observational NAVIGATE arm (single arm study, no comparator)
Diagnostic Yield	822 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects with a True Positive (TP) for Malignancy or False Negative (FN) for Malignancy diagnosis by 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 / \[TP+FN\])

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=858 Participants Observational NAVIGATE arm (single arm study, no comparator)
Sensitivity	537 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects with a False Positive (FP) for Malignancy or True Negative (TN) for Malignancy diagnosis by 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 / \[FP+TN\])

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=285 Participants Observational NAVIGATE arm (single arm study, no comparator)
Specificity	285 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects with a True Positive (TP) for Malignancy or False Positive (FP) for Malignancy diagnosis by 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 / \[TP+FP\])

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=537 Participants Observational NAVIGATE arm (single arm study, no comparator)
Positive Predictive Value	537 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects with a False Negative (FN) for Malignancy or True Negative (TN) for Malignancy diagnosis by 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 / \[FN+TN\])

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=606 Participants Observational NAVIGATE arm (single arm study, no comparator)
Negative Predictive Value	285 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects with navigation complete and tissue obtained

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.

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=1260 Participants Observational NAVIGATE arm (single arm study, no comparator)
Repeat Biopsy Rate	334 Participants

SECONDARY outcome

Timeframe: at index procedure visit

Population: 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.

Tissue adequacy for molecular genetic testing (if applicable).

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=110 Lesions Observational NAVIGATE arm (single arm study, no comparator)
Tissue Adequacy for Molecular Genetic Testing	89 Lesions

SECONDARY outcome

Timeframe: up to 24 months

Population: 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.

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

Outcome measures

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

SECONDARY outcome

Timeframe: up to 24 months

Population: Number of subjects diagnosed with primary lung cancer.

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

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=468 Participants Observational NAVIGATE arm (single arm study, no comparator)
Stage at Diagnosis Stage I	251 Participants
Stage at Diagnosis Stage II	52 Participants
Stage at Diagnosis Stage III	81 Participants
Stage at Diagnosis Stage IV	84 Participants

SECONDARY outcome

Timeframe: at index procedure visit

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

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.

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=269 Participants Observational NAVIGATE arm (single arm study, no comparator)
Success Rate of Accurate Placement of Fiducial Markers	253 Participants

SECONDARY outcome

Timeframe: at index procedure visit

Population: Number of subjects where ENB was used to aid in pleural 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.

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=23 Participants Observational NAVIGATE arm (single arm study, no comparator)
Success Rate of Dye Marking	21 Participants

SECONDARY outcome

Timeframe: at index procedure visit

Population: Number of subjects where ENB was used to aid in 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.

Outcome measures

Outcome measures
Measure	NAVIGATE (Single Arm Study) n=36 Participants Observational NAVIGATE arm (single arm study, no comparator)
Success Rate of Obtaining Lymph Node Biopsy	31 Participants

Adverse Events

NAVIGATE (Single Arm Study)

Serious events: 497 serious events

Other events: 96 other events

Deaths: 403 deaths

Serious adverse events

Serious adverse events
Measure	NAVIGATE (Single Arm Study) n=1388 participants at risk Observational NAVIGATE arm (single arm study, no comparator)
Blood and lymphatic system disorders Thrombocytopenia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Cardiac disorders Acute myocardial infarction	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Cardiac disorders Cardiac arrest	0.65% 9/1388 • Number of events 9 • Up to 24 months post procedure 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.
Cardiac disorders Cardiac failure	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Cardiac disorders Cardiac failure congestive	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Cardiac disorders Cardio-respiratory arrest	1.2% 16/1388 • Number of events 16 • Up to 24 months post procedure 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.
Cardiac disorders Cardiopulmonary failure	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Cardiac disorders Cor pulmonale acute	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Cardiac disorders Left ventricular failure	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Cardiac disorders Myocardial infarction	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Gastrointestinal disorders Inguinal hernia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Gastrointestinal disorders Intestinal infarction	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Gastrointestinal disorders Intestinal perforation	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Gastrointestinal disorders Pancreatitis	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
General disorders Death	6.2% 86/1388 • Number of events 86 • Up to 24 months post procedure 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.
General disorders Disease progression	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
General disorders Multiple organ dysfunction syndrome	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Hepatobiliary disorders Acute hepatic failure	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Hepatobiliary disorders Cirrhosis alcoholic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Hepatobiliary disorders Hepatorenal syndrome	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Infections and infestations Bacteraemia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Infections and infestations Bacterial sepsis	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Infections and infestations Lower respiratory tract infection	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Infections and infestations Pneumonia	0.50% 7/1388 • Number of events 7 • Up to 24 months post procedure 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.
Infections and infestations Pneumonia fungal	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Infections and infestations Sepsis	0.36% 5/1388 • Number of events 5 • Up to 24 months post procedure 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.
Infections and infestations Septic shock	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Infections and infestations Transmission of an infectious agent via product	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Injury, poisoning and procedural complications Gun shot wound	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Injury, poisoning and procedural complications Procedural pneumothorax	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Metabolism and nutrition disorders Failure to thrive	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Metabolism and nutrition disorders Hyperglycaemia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.29% 4/1388 • Number of events 4 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	1.3% 18/1388 • Number of events 18 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.7% 23/1388 • Number of events 23 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.29% 4/1388 • Number of events 4 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	3.2% 45/1388 • Number of events 45 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage IV	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma malignant	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pulmonary embolism	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic uterine cancer	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.29% 4/1388 • Number of events 4 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.36% 5/1388 • Number of events 5 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyosarcoma	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Nervous system disorders Cerebral infarction	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Nervous system disorders Cerebrovascular accident	0.29% 4/1388 • Number of events 4 • Up to 24 months post procedure 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.
Renal and urinary disorders Goodpasture's syndrome	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Renal and urinary disorders Renal failure	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.58% 8/1388 • Number of events 8 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Apnoea	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.22% 3/1388 • Number of events 3 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.07% 1/1388 • Number of events 2 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.8% 81/1388 • Number of events 83 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.14% 2/1388 • Number of events 2 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.1% 15/1388 • Number of events 15 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.0% 111/1388 • Number of events 138 • Up to 24 months post procedure 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.
Vascular disorders Arteriosclerosis	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Vascular disorders Arteriovenous fistula	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.
Vascular disorders Peripheral circulatory failure	0.07% 1/1388 • Number of events 1 • Up to 24 months post procedure 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.

Other adverse events

Other adverse events
Measure	NAVIGATE (Single Arm Study) n=1388 participants at risk Observational NAVIGATE arm (single arm study, no comparator)
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.2% 72/1388 • Number of events 73 • Up to 24 months post procedure 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.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.7% 24/1388 • Number of events 24 • Up to 24 months post procedure 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.

Additional Information

Jennifer Wolvers

Medtronic

Phone: 763-258-9405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER