superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585959
• Other study ID #: MDT18004ILSFNV
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: February 18, 2019

Study information

• Verified date: April 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 18, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• superDimension™ Navigation System Version 7.2
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy

Locations

Country	Name	City	State
United States	CHI Memorial Medical Group	Chattanooga	Tennessee
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tool Order	Tool order analysis reports the number of times that a tool was used first in a patient.	day of procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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