Trial Outcomes & Findings for Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration (NCT NCT04250194)

NCT ID: NCT04250194

Last Updated: 2025-09-29

Results Overview

Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following: * Malignant, OR * Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR * Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND * Absence of malignancy (true negative) through 1-year CT follow-up, defined as: * The nodule markedly regresses or resolves on follow-up imaging, OR * A persistent nodule has not been diagnosed as malignant, AND * No plans for repeat invasive diagnostic procedures through 12 months follow-up. Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 288 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2025-09-29

Participant Flow

288 participants were consented, 30 participants were excluded prior to randomization: * Failed central adjudication of procedure feasibility (n=20) * Withdrawal of informed consent (n=5) * New data available meeting exclusion criterion (n=5)

Participant milestones

Measure	Navigation Bronchoscopy (NB) With F-Nav Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
Overall Study STARTED	129	129
Overall Study COMPLETED	121	113
Overall Study NOT COMPLETED	8	16

Reasons for withdrawal

Measure	Navigation Bronchoscopy (NB) With F-Nav Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
Overall Study Declined to schedule biopsy	6	10
Overall Study Medically Unfit for Biopsy	2	1
Overall Study New data available meeting exclusion criterion: PET/CT with avid adenopathy	0	2
Overall Study New data available meeting exclusion criterion: interim CT demonstrated rapid growth to >30 mm	0	2
Overall Study New data available meeting exclusion criterion: PET/CT with avid endobronchial lesion	0	1

Baseline Characteristics

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Baseline characteristics by cohort

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Total n=234 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	68 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	57 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=5 Participants	110 Participants n=7 Participants	231 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	105 Participants n=7 Participants	215 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Comorbidities Current or prior malignancy	46 Participants n=5 Participants	55 Participants n=7 Participants	101 Participants n=5 Participants
Comorbidities Chronic Obstructive Pulmonary Disease (COPD)	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Comorbidities Coronary artery disease	25 Participants n=5 Participants	16 Participants n=7 Participants	41 Participants n=5 Participants
Body Mass Index	27.6 kg/m^2 n=5 Participants	27.9 kg/m^2 n=7 Participants	27.7 kg/m^2 n=5 Participants
Tobacco smoking history Current	39 Participants n=5 Participants	24 Participants n=7 Participants	63 Participants n=5 Participants
Tobacco smoking history Former	55 Participants n=5 Participants	66 Participants n=7 Participants	121 Participants n=5 Participants
Tobacco smoking history Non-smoker	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Pack-years	43 pack-years n=5 Participants	35 pack-years n=7 Participants	40.0 pack-years n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Our protocol excluded those missing primary outcome data from the primary outcome analysis. The primary outcome was adjudicated as 12 months and five patients were lost to follow-up (2 in NB group, 3 in CT-guided Biopsy group). These represent the difference in these denominators for this analysis compared to overall patient numbers. The overall patient numbers (121 an 113) were used as base denominators for all other outcomes.

Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following:

• Malignant, OR
• Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR
• Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND
• Absence of malignancy (true negative) through 1-year CT follow-up, defined as:

• The nodule markedly regresses or resolves on follow-up imaging, OR
• A persistent nodule has not been diagnosed as malignant, AND
• No plans for repeat invasive diagnostic procedures through 12 months follow-up.

Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=119 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=110 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Diagnostic Accuracy	94 Participants	81 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Diagnostic Yield	96 Participants	88 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Proportion of cases complicated by pneumothorax

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Rate of Pneumothorax	4 Participants	32 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Proportion of cases complicated by pneumothorax requiring chest tube placement

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Rate of Pneumothorax Requiring Chest Tube Placement	1 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Proportion of cases with complication necessitating hospitalization after a procedure

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Need for Hospitalization After Procedure	1 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Total time required to complete the procedure

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Duration of Procedure	36 minutes Interval 28.0 to 47.5	24.5 minutes Interval 13.0 to 36.0	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=119 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=94 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic n=25 Participants Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Type of Biopsy) Transbronchial biopsy (TBB) using forceps	76 Participants	64 Participants	12 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) Transbronchial needle aspiration (TBNA)	116 Participants	93 Participants	23 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) Peripheral brushing with standard brush	22 Participants	17 Participants	5 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) Triple needle brushing	2 Participants	2 Participants	0 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) GenCut biopsy tool	3 Participants	1 Participants	2 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) Peripheral wash via navigation catheter	31 Participants	22 Participants	9 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy) Any specimen cultured	25 Participants	15 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=119 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=94 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic n=25 Participants Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Number of Biopsies) TBNA needle passes	8.0 number of biopsies Interval 6.0 to 8.2	8.0 number of biopsies Interval 6.0 to 8.0	8.0 number of biopsies Interval 6.5 to 10.0
Procedural Factors Associated With Improved Yield (Number of Biopsies) Forceps TBB pass count	5.0 number of biopsies Interval 4.0 to 6.0	5.0 number of biopsies Interval 4.0 to 6.0	5.0 number of biopsies Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=119 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=94 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic n=25 Participants Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) Initial Radial Endobronchial Ultrasound (REBUS) signature: Concentric	20 Participants	20 Participants	0 Participants
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) Initial REBUS signature: Eccentric	39 Participants	30 Participants	9 Participants
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) Initial REBUS signature: Could not localize	47 Participants	32 Participants	15 Participants
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) REBUS not used during procedure	13 Participants	12 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Each trial arm is being split into two groups, whether a bronchus sign was present or absent. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.

Association of diagnostic yield with presence of a bronchus sign

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) Presence of a bronchus sign	37 Participants	30 Participants	—
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) Without a bronchus sign	59 Participants	58 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Each trial arm is being split into two groups, whether the lung nodule is in the outer-third zone or middle-third zone. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.

Association of diagnostic yield with biopsy site (nodule location)

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Biopsy Site) Nodule is in outer-third zone	86 Participants	77 Participants	—
Procedural Factors Associated With Improved Yield (Biopsy Site) Nodule is in middle-third zone	10 Participants	11 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Need for Additional Nodule Biopsy	16 Participants	15 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Proportion of cases in which a subsequent procedure was performed for staging

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Need for Additional Procedure for Staging	0 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: The NB arm has units of mGy\*cm\^2.

Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy*cm^2)

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Radiation Exposure From Fluoroscopy-guided Bronchoscopy	9800 mGy*cm^2 Interval 7190.0 to 18850.0	—	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=119 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=94 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic n=25 Participants Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Need for F-Nav During Navigation Bronchoscopy	96 Participants	71 Participants	25 Participants

SECONDARY outcome

Timeframe: Up to 12 months

The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Confident Clinical Diagnosis	96 Participants	88 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: CT-guided biopsy arm has units of mGy\*cm

Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy*cm)

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=113 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Radiation Exposure From CT for CT-guided Biopsy	659 mGy*cm Interval 253.0 to 1276.0	—	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: 16 patients not included: CT performed on the day of the procedure demonstrated regressing nodules in 10 patients and the proceduralist decided to cancel in 6 patients. There were pre-specified exclusion criteria for this outcome measure. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.

Outcome measures

Measure	Navigation Bronchoscopy (NB) With F-Nav n=97 Participants Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=78 Participants CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing	Nondiagnostic n=19 Participants Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Core biopsy gauge: 18 or 19	6 Participants	4 Participants	2 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Core biopsy gauge: 20 or 21	83 Participants	74 Participants	9 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Any specimen cultured	8 Participants	8 Participants	0 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Coaxial needle gauge : <19	6 Participants	4 Participants	2 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Coaxial needle gauge : 19	75 Participants	64 Participants	11 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Coaxial needle gauge : 20	12 Participants	9 Participants	3 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Coaxial needle gauge : Not used	4 Participants	1 Participants	3 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group FNA performed	6 Participants	4 Participants	2 Participants
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group Core biopsies performed	89 Participants	78 Participants	11 Participants

Adverse Events

Navigation Bronchoscopy (NB) With F-Nav

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

CT-guided Biopsy

Serious events: 14 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 participants at risk Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 participants at risk CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.83% 1/121 • 12 months	11.5% 13/113 • 12 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.83% 1/121 • 12 months	0.88% 1/113 • 12 months

Other adverse events

Measure	Navigation Bronchoscopy (NB) With F-Nav n=121 participants at risk Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy	CT-guided Biopsy n=113 participants at risk CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.5% 3/121 • 12 months	16.8% 19/113 • 12 months
Blood and lymphatic system disorders Hemorrhage requiring intervention	0.00% 0/121 • 12 months	0.00% 0/113 • 12 months
Cardiac disorders Acute coronary syndrome	0.83% 1/121 • 12 months	0.00% 0/113 • 12 months

Additional Information

Dr. Fabien Maldonado

Vanderbilt University Medical Center

Phone: 615-322-2386

Email: fabien.maldonado@vumc.org

Results disclosure agreements

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