superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
- Conditions
- Lung Cancer
- Interventions
- Device: superDimension™ Navigation System Version 7.2
- Registration Number
- NCT03585959
- Lead Sponsor
- Medtronic - MITG
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fluoroscopic Navigation Arm superDimension™ Navigation System Version 7.2 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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 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.
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.
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.
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".
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.
Tool Order day of procedure Tool order analysis reports the number of times that a tool was used first in a patient.
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.
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.
Trial Locations
- Locations (2)
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
CHI Memorial Medical Group
🇺🇸Chattanooga, Tennessee, United States