Lung Cancer
Conditions
Brief summary
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Detailed description
The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.
Interventions
DEVICEsuperDimension™ Navigation System Version 7.2
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation 2. Lesion is intended to be biopsied by the participating investigator 3. Subject is willing and able to provide informed consent to participate in the study 4. Subject is a candidate for an elective ENB procedure 5. Subject is over the age of 18
Exclusion criteria
1. Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB 2. Lesions within 10 mm of the diaphragm 3. The subject is unable or unwilling to comply with study follow-up schedule 4. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 5. Female subjects who are pregnant or nursing as determined by standard site practices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm the Location Accuracy of the Local Registration Feature | day of procedure | The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT). The primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases That Are Not Technically Successful (Local Registration Not Complete) | day of procedure | By device design, if the local registration algorithm determines that the correction distance is greater than 3.0 cm the location of the virtual target will not be updated. These cases are not considered technically successful according to the clinical study definitions, even though the device performed as designed. |
| Investigator Confirmation That the Catheter is in an Adequate Periprocedural Location Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology. | day of procedure | Investigator confirmation that the catheter was in an adequate periprocedural location (the location of the extended working channel when the proceduralist made the decision that placement was adequate and clinically acceptable to proceed with tissue sampling). Adequate periprocedural location is reported with use of local registration. |
| Total Procedure Time | day of procedure | Total time from the first entry of the bronchoscope to the final removal of the bronchoscope. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice |
| ENB Procedure Time | day of procedure | ENB procedure time captured in the electronic data capture database being utilized for the study defined as the total time from the first entry of the extended working channel or locatable guide until the last exit of the extended working channel. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice |
| Total Fluoroscopy Time | day of procedure | Total fluoroscopy time captured in the electronic data capture database being utilized for the study was determined to not be clinically relevant. Instead, the fluoroscopic navigation time is presented. Fluoroscopic Navigation Time: Two sweeps pooled. Encompasses c-arm sweep, target marking, and algorithm computational time, inclusive of the initiation of the local registration applet to the time the updated catheter location was ready and on screen (not including CBCT), as measured by the system software |
| Adequacy of the ENB-aided Tissue Sample | Based on final pathology results of the ENB-aided biopsy sample collected day of procedure | Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.ROSE results could be reported as Benign, Inconclusive, Malignant, Inadequate Tissue for ROSE, or N/A. If all ROSE diagnoses were report as Inadequate Tissue for ROSE, for a participant, then the case was considered as Inadequate Tissue. |
| Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) | day of procedure | Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design. |
| Number of Cases That Are Technically Successful (Successful Completion of Local Registration) | day of procedure | Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology. |
| Biopsy Tools Used | day of procedure | Biopsy tools used was captured in the electronic data capture database being utilized for the study on all subjects with local registration attempted. If subject use same tool more than once, only counts once. |
| Tool Order | day of procedure | Tool order analysis reports the number of times that a tool was used first in a patient. |
| Number of Tool Pases | day of procedure | An analysis of the number of passes for each tool was planned, but it was determined that it wouldn't be clinically meaningful to go into that level of detail for the analysis and instead focused on the number of passes for only the first tool used. |
| Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | Based on ROSE results of the ENB-aided biopsy sample collected day of procedure | The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design. |
| Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Based on final pathology results of the ENB-aided sample collected day of procedure | The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design. |
| Percentage of Cases in Which the Intended Lesion is Correctly Identified | day of procedure | In technically successful cases (local registration complete) the percentage of cases in which the intended lesion is correctly identified (as opposed to a non-target lesion or normal lung tissue) as indicated by the system software. |
| Relational Accuracy in Cases in Which the Intended Lesion is Targeted | day of procedure | In Technically successful cases (local registration complete) with evaluable videos the relational accuracy in cases in which the intended lesion is targeted was assessed. Relational accuracy is defined as the three-dimensional percentage overlap between the virtual target and the actual lesion in CBCT before (FNAV/CBCT 1) and after (FNAV/CBCT 2) correction of the catheter location. |
| Final Pathology Results of the ENB-aided Tissue Sample | Based on final pathology results of the ENB-aided biopsy sample collected day of procedure | Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluoroscopic Navigation Arm An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Unsuccessful Procedure | 2 |
Baseline characteristics
| Characteristic | Fluoroscopic Navigation Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 69.8 years STANDARD_DEVIATION 7.7 |
| Lesion Characteristics Bronchus Sign Present on CT | 26 lesion |
| Lesion Characteristics Lesion < 20 mm | 30 lesion |
| Lesion Characteristics Pure to mostly solid (Suzuki Class 5 or 6) | 49 lesion |
| Lesion Characteristics Upper Lobe Location | 32 lesion |
| Medical History Chronic Obstructive Pulmonary Disease (COPD) | 31 participants |
| Medical History Tobacco Use | 44 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Black of African American | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 43 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 7 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Confirm the Location Accuracy of the Local Registration Feature
The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT). The primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success.
Time frame: day of procedure
Population: 47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Technically Successful Cases, FNAV/CBCT 1 | Target overlap achieved | 28 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Technically Successful Cases, FNAV/CBCT 1 | Target overlap not achieved | 19 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Technically Successful Cases, FNAV/CBCT 2 | Target overlap achieved | 39 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Technically Successful Cases, FNAV/CBCT 2 | Target overlap not achieved | 8 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Evaluable Cases, FNAV/CBCT 1 | Target overlap achieved | 28 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Evaluable Cases, FNAV/CBCT 1 | Target overlap not achieved | 13 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Evaluable Cases, FNAV/CBCT 2 | Target overlap achieved | 39 Participants |
| Fluoroscopic Navigation Arm | Confirm the Location Accuracy of the Local Registration Feature | All Evaluable Cases, FNAV/CBCT 2 | Target overlap not achieved | 2 Participants |
Secondary
Adequacy of the ENB-aided Tissue Sample
Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.ROSE results could be reported as Benign, Inconclusive, Malignant, Inadequate Tissue for ROSE, or N/A. If all ROSE diagnoses were report as Inadequate Tissue for ROSE, for a participant, then the case was considered as Inadequate Tissue.
Time frame: Based on final pathology results of the ENB-aided biopsy sample collected day of procedure
Population: ROSE was attempted in 49/49 cases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoroscopic Navigation Arm | Adequacy of the ENB-aided Tissue Sample | 49 Participants |
Secondary
Biopsy Tools Used
Biopsy tools used was captured in the electronic data capture database being utilized for the study on all subjects with local registration attempted. If subject use same tool more than once, only counts once.
Time frame: day of procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Biopsy Tools Used | Aspiration Needle | 42 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | Biopsy Forceps | 33 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | GenCut Core Biopsy Tool | 10 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | Cytology Brush | 49 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | superDimension triple needle cytology brush | 2 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | superDimension needle-tipped cytology brush | 2 tool use |
| Fluoroscopic Navigation Arm | Biopsy Tools Used | Bronchoalveolar lavage/washing | 30 tool use |
Secondary
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample
The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.
Time frame: Based on ROSE results of the ENB-aided biopsy sample collected day of procedure
Population: Patients with overall malignant results by ROSE (26/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case. Bronchoalveolar Lavage is not applicable for ROSE.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | Aspirating Needle | 15 participants |
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | Biopsy Forcep | 2 participants |
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | Cytology Brush | 9 participants |
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | superDimension Needle-Tipped Cytology Brush | 2 participants |
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | Gencut Core Biopsy Tool | 3 participants |
| Fluoroscopic Navigation Arm | Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample | superDimension Triple Needle Cytology Brush | 1 participants |
Secondary
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample
The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.
Time frame: Based on final pathology results of the ENB-aided sample collected day of procedure
Population: Patients with overall malignant results by Pathology (30/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Aspirating Needle | 21 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Biopsy Forceps | 12 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Cytology Brush | 20 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | superDimension Needle-Tipped Cytology Brush | 2 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Gencut Core Biopsy Tool | 5 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | superDimension Triple Needle cytology Brush | 1 malignant results |
| Fluoroscopic Navigation Arm | Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample | Bronchoalveolar Lavage | 10 malignant results |
Secondary
ENB Procedure Time
ENB procedure time captured in the electronic data capture database being utilized for the study defined as the total time from the first entry of the extended working channel or locatable guide until the last exit of the extended working channel. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice
Time frame: day of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoroscopic Navigation Arm | ENB Procedure Time | 54.3 Minutes | Standard Deviation 20.5 |
Secondary
Final Pathology Results of the ENB-aided Tissue Sample
Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.
Time frame: Based on final pathology results of the ENB-aided biopsy sample collected day of procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Final Pathology Results of the ENB-aided Tissue Sample | Malignant | 30 Participants |
| Fluoroscopic Navigation Arm | Final Pathology Results of the ENB-aided Tissue Sample | Other | 19 Participants |
Secondary
Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)
Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.
Time frame: day of procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) | Malignant | 26 Participants |
| Fluoroscopic Navigation Arm | Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) | Other | 23 Participants |
Secondary
Investigator Confirmation That the Catheter is in an Adequate Periprocedural Location Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.
Investigator confirmation that the catheter was in an adequate periprocedural location (the location of the extended working channel when the proceduralist made the decision that placement was adequate and clinically acceptable to proceed with tissue sampling). Adequate periprocedural location is reported with use of local registration.
Time frame: day of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoroscopic Navigation Arm | Investigator Confirmation That the Catheter is in an Adequate Periprocedural Location Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology. | 47 Participants |
Secondary
Number of Cases That Are Not Technically Successful (Local Registration Not Complete)
By device design, if the local registration algorithm determines that the correction distance is greater than 3.0 cm the location of the virtual target will not be updated. These cases are not considered technically successful according to the clinical study definitions, even though the device performed as designed.
Time frame: day of procedure
Population: 2 of 49 cases did not complete local registration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoroscopic Navigation Arm | Number of Cases That Are Not Technically Successful (Local Registration Not Complete) | 2 Participants |
Secondary
Number of Cases That Are Technically Successful (Successful Completion of Local Registration)
Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.
Time frame: day of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoroscopic Navigation Arm | Number of Cases That Are Technically Successful (Successful Completion of Local Registration) | 47 Participants |
Secondary
Number of Tool Pases
An analysis of the number of passes for each tool was planned, but it was determined that it wouldn't be clinically meaningful to go into that level of detail for the analysis and instead focused on the number of passes for only the first tool used.
Time frame: day of procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluoroscopic Navigation Arm | Number of Tool Pases | Arcpoint pulmonary needle | 6 passes | Standard Deviation 4.2 |
| Fluoroscopic Navigation Arm | Number of Tool Pases | Aspirating needle, superDimension | 9 passes | Standard Deviation 2.8 |
| Fluoroscopic Navigation Arm | Number of Tool Pases | Cytology brush, non-superDimension | 2 passes | Standard Deviation 0 |
| Fluoroscopic Navigation Arm | Number of Tool Pases | Cytology brush, superDimension | 4 passes | Standard Deviation 1.8 |
Secondary
Percentage of Cases in Which the Intended Lesion is Correctly Identified
In technically successful cases (local registration complete) the percentage of cases in which the intended lesion is correctly identified (as opposed to a non-target lesion or normal lung tissue) as indicated by the system software.
Time frame: day of procedure
Population: 38 subjects had adequate video files to assess this endpoint
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Percentage of Cases in Which the Intended Lesion is Correctly Identified | correct identification of intended lesion | 38 Participants |
| Fluoroscopic Navigation Arm | Percentage of Cases in Which the Intended Lesion is Correctly Identified | incorrect identification of intended lesion | 0 Participants |
Secondary
Relational Accuracy in Cases in Which the Intended Lesion is Targeted
In Technically successful cases (local registration complete) with evaluable videos the relational accuracy in cases in which the intended lesion is targeted was assessed. Relational accuracy is defined as the three-dimensional percentage overlap between the virtual target and the actual lesion in CBCT before (FNAV/CBCT 1) and after (FNAV/CBCT 2) correction of the catheter location.
Time frame: day of procedure
Population: 47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Relational Accuracy in Cases in Which the Intended Lesion is Targeted | Relational accuracy, Before location correction | 11.4 3D percent overlap |
| Fluoroscopic Navigation Arm | Relational Accuracy in Cases in Which the Intended Lesion is Targeted | Relational accuracy, after location correction | 32.8 3D percent overlap |
Secondary
Tool Order
Tool order analysis reports the number of times that a tool was used first in a patient.
Time frame: day of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Tool Order | Aspirating needle | 26 Participants |
| Fluoroscopic Navigation Arm | Tool Order | Cytology brush | 23 Participants |
Secondary
Total Fluoroscopy Time
Total fluoroscopy time captured in the electronic data capture database being utilized for the study was determined to not be clinically relevant. Instead, the fluoroscopic navigation time is presented. Fluoroscopic Navigation Time: Two sweeps pooled. Encompasses c-arm sweep, target marking, and algorithm computational time, inclusive of the initiation of the local registration applet to the time the updated catheter location was ready and on screen (not including CBCT), as measured by the system software
Time frame: day of procedure
Population: Four cases were considered technically successful but could not be analyzed due to inadequate video recording and an additional four technically successful cases had data from only FNAV/CBCT 1 (n=2) or only FNAV/CBCT 2 (n=2), resulting in evaluable datasets of 41 subjects per FNAV/CBCT group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fluoroscopic Navigation Arm | Total Fluoroscopy Time | 3.8 Minutes |
Secondary
Total Procedure Time
Total time from the first entry of the bronchoscope to the final removal of the bronchoscope. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice
Time frame: day of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Total Procedure Time | 65.3 minutes | Standard Deviation 22.4 |