Trial Outcomes & Findings for Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling (NCT NCT05599321)
NCT ID: NCT05599321
Last Updated: 2026-05-15
Results Overview
Presence or absence of adverse events during a procedure
Recruitment status
COMPLETED
Target enrollment
110 participants
Primary outcome timeframe
One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Results posted on
2026-05-15
Participant Flow
Participant milestones
| Measure |
Historical Controls Cohort - Peripheral Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
11
|
24
|
14
|
|
Overall Study
COMPLETED
|
56
|
9
|
24
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
Baseline characteristics by cohort
| Measure |
Historical Controls Cohort - Peripheral Arm
n=58 Regions of interest (ROI)
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
n=17 Regions of interest (ROI)
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Historical Controls Cohort - Central Arm
n=65 Regions of interest (ROI)
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=74 Regions of interest (ROI)
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Total
n=214 Regions of interest (ROI)
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=186 Participants
|
39 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
16 Participants
n=20 Participants
|
7 Participants
n=186 Participants
|
63 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=20 Participants
|
7 Participants
n=186 Participants
|
56 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=20 Participants
|
6 Participants
n=186 Participants
|
46 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
3 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
23 Participants
n=20 Participants
|
12 Participants
n=186 Participants
|
99 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
22 Participants
n=20 Participants
|
13 Participants
n=186 Participants
|
92 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
2 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Presence or absence of adverse events during a procedure
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=56 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=24 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=9 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=13 Participants
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Measurement
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: This outcome measure does not apply to the historical control cohort since there was no clinical use of the VN system during these bronchoscopies.
Presence or absence of software malfunctions in the VN System during bronchoscopic procedure
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=17 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=74 ROI
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Functionality Measurement
|
—
|
0 Software malfunctions
|
—
|
0 Software malfunctions
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: This outcome measure is not applicable to the consented clinical bronchoscopy cohort. For the clinical bronchoscopy cohort, we focused on identifying and visualizing the regions of interest.
Comparison of diagnostic biopsy yield between the historical controls and consented live cases
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=58 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=65 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Diagnostic Biopsy Yield
|
35 Adequate biopsies
|
—
|
45 Adequate biopsies
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: The Radial Endobronchial Ultrasound (EBUS) Probe is only used for localizing peripheral lesions and is not used for nodal staging. We note that only 36 of the 56 total patients considered in the Historical Controls Cohort - Peripheral arm used radial probe EBUS.
Number of Passes of the Radial Endobronchial Ultrasound (EBUS) Probe per ROI
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=36 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=17 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Radial Endobronchial Ultrasound (EBUS) Probe Passes
|
7.7 Number of passes per ROI
Interval 0.0 to 13.0
|
1 Number of passes per ROI
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: This is not applicable to the peripheral arms of both cohorts because lymph nodes and nodal stations are not visited during those procedures. The peripheral arms are concerned with diagnosis of peripheral lesions.
Comparison of number of lymph nodes and nodal stations visited between the live cases and historical controls
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=24 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=13 Participants
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of the Number of Lymph Nodes and Nodal Stations Visited
|
—
|
—
|
2.67 Nodes and stations visited per case
Interval 1.0 to 4.0
|
5.69 Nodes and stations visited per case
Interval 5.0 to 6.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: This outcome measure is not applicable to the consented clinical bronchoscopy cohort. For the clinical bronchoscopy cohort, we focused on identifying and visualizing the regions of interest. We note that the 45 participants analyzed in the Historical Controls Cohort - Peripheral Arm is less than the 56 participants considered for this arm; this information was not available for all of the historical cases.
Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=45 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=65 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Tumor Pathology
Indeterminant
|
6 ROI
|
—
|
2 ROI
|
—
|
—
|
—
|
—
|
—
|
|
Tumor Pathology
Malignant
|
20 ROI
|
—
|
8 ROI
|
—
|
—
|
—
|
—
|
—
|
|
Tumor Pathology
Non-malignant
|
7 ROI
|
—
|
37 ROI
|
—
|
—
|
—
|
—
|
—
|
|
Tumor Pathology
Inadequate
|
12 ROI
|
—
|
18 ROI
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Rate of complications from bronchoscopic procedure
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=56 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=24 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=9 Participants
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=13 Participants
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Procedure Complications
|
1 Complications
|
0 Complications
|
0 Complications
|
0 Complications
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Population: This outcome measure was not available in the historical control dataset. Also, this outcome measure only applies to the peripheral arm, which focuses on peripheral lesions, and therefore was not collected for the central arm, which does not consider peripheral lesions. The central arm focused on locating lymph node stations, not distance to the sites.
Distance between actual site selected during the live procedure and the pre-planned, computed optimal biopsy site.
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=17 Biopsy sites
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Distance From Final Selected Site to the Pre-planned Optimal Site
|
—
|
—
|
5.88 distance in millimeters
Interval 1.0 to 15.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.Procedure time (total and per tumor or lymph node) in minutes
Outcome measures
| Measure |
Historical Controls Cohort - Peripheral Arm
n=8 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=48 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Historical Controls Cohort - Central Arm
n=54 ROI
Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=11 ROI
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Central Arm
n=26 ROI
Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
n=2 ROI
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Nodal Staging Time
n=48 ROI
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the nodal staging procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
Consented Clinical Bronchoscopy Cohort - Joint Peripheral/Central Arm: Peripheral Procedure Time
n=15 ROI
Lung cancer patients, scheduled for bronchoscopy for both peripheral nodule biopsy and nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. This particular subgroup considers the time for the peripheral procedure.
Virtual Navigation System: The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.
|
|---|---|---|---|---|---|---|---|---|
|
Procedure Time
|
3540 Seconds
Interval 1680.0 to 6540.0
|
6120 Seconds
Interval 1740.0 to 10380.0
|
3060 Seconds
Interval 1140.0 to 5160.0
|
4140 Seconds
Interval 2700.0 to 5940.0
|
56.7 Seconds
Interval 12.0 to 135.0
|
144 Seconds
Interval 140.0 to 148.0
|
35.3 Seconds
Interval 17.0 to 61.0
|
209 Seconds
Interval 103.0 to 329.0
|
Adverse Events
Historical Controls Cohort - Peripheral Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Consented Clinical Bronchoscopy Cohort - Peripheral Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Controls Cohort - Central Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Consented Clinical Bronchoscopy Cohort - Central Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place