Trial Outcomes & Findings for superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology (NCT NCT03585959)

NCT ID: NCT03585959

Last Updated: 2020-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: day of procedure
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study Physician Decision	1
Overall Study Unsuccessful Procedure	2

Baseline Characteristics

Lesion data is only available in subjects with local registration attempted.

Baseline characteristics by cohort

Measure	Fluoroscopic Navigation Arm n=50 Participants 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.
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=50 Participants
Age, Categorical >=65 years	38 Participants n=50 Participants
Age, Continuous	69.8 years STANDARD_DEVIATION 7.7 • n=50 Participants
Sex: Female, Male Female	35 Participants n=50 Participants
Sex: Female, Male Male	15 Participants n=50 Participants
Race/Ethnicity, Customized Caucasian	43 Participants n=50 Participants
Race/Ethnicity, Customized Black of African American	5 Participants n=50 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=50 Participants
Region of Enrollment United States	50 participants n=50 Participants
Medical History Chronic Obstructive Pulmonary Disease (COPD)	31 participants n=50 Participants
Medical History Tobacco Use	44 participants n=50 Participants
Lesion Characteristics Lesion < 20 mm	30 lesion n=49 Participants • Lesion data is only available in subjects with local registration attempted.
Lesion Characteristics Upper Lobe Location	32 lesion n=49 Participants • Lesion data is only available in subjects with local registration attempted.
Lesion Characteristics Pure to mostly solid (Suzuki Class 5 or 6)	49 lesion n=49 Participants • Lesion data is only available in subjects with local registration attempted.
Lesion Characteristics Bronchus Sign Present on CT	26 lesion n=49 Participants • Lesion data is only available in subjects with local registration attempted.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=47 Participants 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.
Confirm the Location Accuracy of the Local Registration Feature All Technically Successful Cases, FNAV/CBCT 1 · Target overlap achieved	28 Participants
Confirm the Location Accuracy of the Local Registration Feature All Technically Successful Cases, FNAV/CBCT 1 · Target overlap not achieved	19 Participants
Confirm the Location Accuracy of the Local Registration Feature All Technically Successful Cases, FNAV/CBCT 2 · Target overlap achieved	39 Participants
Confirm the Location Accuracy of the Local Registration Feature All Technically Successful Cases, FNAV/CBCT 2 · Target overlap not achieved	8 Participants
Confirm the Location Accuracy of the Local Registration Feature All Evaluable Cases, FNAV/CBCT 1 · Target overlap achieved	28 Participants
Confirm the Location Accuracy of the Local Registration Feature All Evaluable Cases, FNAV/CBCT 1 · Target overlap not achieved	13 Participants
Confirm the Location Accuracy of the Local Registration Feature All Evaluable Cases, FNAV/CBCT 2 · Target overlap achieved	39 Participants
Confirm the Location Accuracy of the Local Registration Feature All Evaluable Cases, FNAV/CBCT 2 · Target overlap not achieved	2 Participants

SECONDARY outcome

Timeframe: day of procedure

Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Number of Cases That Are Technically Successful (Successful Completion of Local Registration)	47 Participants

SECONDARY outcome

Timeframe: day of procedure

Population: 2 of 49 cases did not complete local registration

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=2 Participants 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.
Number of Cases That Are Not Technically Successful (Local Registration Not Complete)	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.	47 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Total Procedure Time	65.3 minutes Standard Deviation 22.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
ENB Procedure Time	54.3 Minutes Standard Deviation 20.5

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Fluoroscopic Navigation Arm n=81 Local Registrations 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.
Total Fluoroscopy Time	3.8 Minutes Interval 0.2 to 7.9

SECONDARY outcome

Timeframe: Based on final pathology results of the ENB-aided biopsy sample collected day of procedure

Population: ROSE was attempted in 49/49 cases.

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".

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Adequacy of the ENB-aided Tissue Sample	49 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) Malignant	26 Participants
Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) Other	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Final Pathology Results of the ENB-aided Tissue Sample Malignant	30 Participants
Final Pathology Results of the ENB-aided Tissue Sample Other	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Biopsy Tools Used Aspiration Needle	42 tool use
Biopsy Tools Used Biopsy Forceps	33 tool use
Biopsy Tools Used GenCut Core Biopsy Tool	10 tool use
Biopsy Tools Used Cytology Brush	49 tool use
Biopsy Tools Used superDimension triple needle cytology brush	2 tool use
Biopsy Tools Used superDimension needle-tipped cytology brush	2 tool use
Biopsy Tools Used Bronchoalveolar lavage/washing	30 tool use

SECONDARY outcome

Timeframe: day of procedure

Tool order analysis reports the number of times that a tool was used first in a patient.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Tool Order Aspirating needle	26 Participants
Tool Order Cytology brush	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=49 Participants 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.
Number of Tool Pases Arcpoint pulmonary needle	6 passes Standard Deviation 4.2
Number of Tool Pases Aspirating needle, superDimension	9 passes Standard Deviation 2.8
Number of Tool Pases Cytology brush, non-superDimension	2 passes Standard Deviation 0
Number of Tool Pases Cytology brush, superDimension	4 passes Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=26 Participants 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.
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample Aspirating Needle	15 participants
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample Biopsy Forcep	2 participants
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample Cytology Brush	9 participants
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample superDimension Needle-Tipped Cytology Brush	2 participants
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample Gencut Core Biopsy Tool	3 participants
Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample superDimension Triple Needle Cytology Brush	1 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=30 Participants 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.
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample Aspirating Needle	21 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample Biopsy Forceps	12 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample Cytology Brush	20 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample superDimension Needle-Tipped Cytology Brush	2 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample Gencut Core Biopsy Tool	5 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample superDimension Triple Needle cytology Brush	1 malignant results
Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample Bronchoalveolar Lavage	10 malignant results

SECONDARY outcome

Timeframe: day of procedure

Population: 38 subjects had adequate video files to assess this endpoint

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=38 Participants 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.
Percentage of Cases in Which the Intended Lesion is Correctly Identified correct identification of intended lesion	38 Participants
Percentage of Cases in Which the Intended Lesion is Correctly Identified incorrect identification of intended lesion	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Fluoroscopic Navigation Arm n=41 Participants 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.
Relational Accuracy in Cases in Which the Intended Lesion is Targeted Relational accuracy, Before location correction	11.4 3D percent overlap Interval 0.0 to 97.0
Relational Accuracy in Cases in Which the Intended Lesion is Targeted Relational accuracy, after location correction	32.8 3D percent overlap Interval 0.0 to 100.0

Adverse Events

Fluoroscopic Navigation Arm

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure

Fluoroscopic Navigation Arm n=50 participants at risk 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. superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy

Infections and infestations Infection

2.0% 1/50 • Number of events 1 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.

Other adverse events

Measure	Fluoroscopic Navigation Arm n=50 participants at risk 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. superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.0% 3/50 • Number of events 3 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/50 • Number of events 1 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.
Nervous system disorders Dizziness	2.0% 1/50 • Number of events 1 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.
Renal and urinary disorders Urinary Retention	2.0% 1/50 • Number of events 1 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/50 • Number of events 1 • Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure. An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.

Additional Information

Katie Bayliss

Medtronic

Phone: (763) 647-5547

Email: katie.j.bayliss@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution/Investigator may publish the results of work performed under this Agreement, in accordance with the Publication Policy described in the Clinical Investigation Plan and publication guidelines from the Declaration of Helsinki. Institution and Investigator shall not publish the Study results until after Medtronic's Multi-site publication or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs first.
• Publication restrictions are in place

Restriction type: OTHER