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superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585959
Recruitment Status : Completed
First Posted : July 13, 2018
Results First Posted : April 7, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: superDimension™ Navigation System Version 7.2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : August 3, 2018
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: superDimension™ Navigation System Version 7.2
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy




Primary Outcome Measures :
  1. Confirm the Location Accuracy of the Local Registration Feature [ Time Frame: 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 :
  1. Number of Cases That Are Technically Successful (Successful Completion of Local Registration) [ Time Frame: day of procedure ]
    Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.

  2. Number of Cases That Are Not Technically Successful (Local Registration Not Complete) [ Time Frame: 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.

  3. Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology. [ Time Frame: 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.

  4. Total Procedure Time [ Time Frame: 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

  5. ENB Procedure Time [ Time Frame: 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

  6. Total Fluoroscopy Time [ Time Frame: 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

  7. Adequacy of the ENB-aided Tissue Sample [ Time Frame: 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".

  8. Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) [ Time Frame: 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.

  9. Final Pathology Results of the ENB-aided Tissue Sample [ Time Frame: 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.

  10. Biopsy Tools Used [ Time Frame: 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.

  11. Tool Order [ Time Frame: day of procedure ]
    Tool order analysis reports the number of times that a tool was used first in a patient.

  12. Number of Tool Pases [ Time Frame: 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.

  13. Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample [ Time Frame: 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.

  14. Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample [ Time Frame: 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.

  15. Percentage of Cases in Which the Intended Lesion is Correctly Identified [ Time Frame: 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.

  16. Relational Accuracy in Cases in Which the Intended Lesion is Targeted [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585959


Locations
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United States, North Carolina
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
United States, Tennessee
CHI Memorial Medical Group
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Michael A. Pritchett, DO MPH FirstHealth Moore Regional Hospital
Principal Investigator: Krishnendu Bhadra, MD CHI Memorial Medical Group
  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:
Statistical Analysis Plan  [PDF] May 21, 2019

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03585959    
Other Study ID Numbers: MDT18004ILSFNV
First Posted: July 13, 2018    Key Record Dates
Results First Posted: April 7, 2020
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No