superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: superDimension™ Navigation System Version 7.2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation Lesion is intended to be biopsied by the participating investigator Subject is willing and able to provide informed consent to participate in the study Subject is a candidate for an elective ENB procedure Subject is over the age of 18 Exclusion Criteria: Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB Lesions within 10 mm of the diaphragm The subject is unable or unwilling to comply with study follow-up schedule The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study Female subjects who are pregnant or nursing as determined by standard site practices

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoroscopic Navigation Arm<br>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. | Device: superDimension™ Navigation System Version 7.2<br>* superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day of procedure | 
| 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. | day of procedure | 
| 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. | day of procedure | 
| 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 | day of procedure | 
| 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 | day of procedure | 
| 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 | day of procedure | 
| 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. | Based on final pathology results of the ENB-aided biopsy sample collected day of procedure | 
| 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. | day of procedure | 
| 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. | Based on final pathology results of the ENB-aided biopsy sample collected day of procedure | 
| 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. | day of procedure | 
| Tool Order | Tool order analysis reports the number of times that a tool was used first in a patient. | day of procedure | 
| 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. | day of procedure | 
| 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. | Based on ROSE results of the ENB-aided biopsy sample collected day of procedure | 
| 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. | Based on final pathology results of the ENB-aided sample collected day of procedure | 
| 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. | day of procedure | 
| 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. | day of procedure |