The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
CHI Memorial Medical Group
Chattanooga, Tennessee, United States
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
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
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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: day of procedure
Tool Order
Tool order analysis reports the number of times that a tool was used first in a patient.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: day of procedure