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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroscopic Navigation Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| superDimension™ Navigation System Version 7.2 | Device | superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Pritchett, DO MPH | FirstHealth Moore Regional Hospital | Principal Investigator |
| Krishnendu Bhadra, MD | CHI Memorial Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States | ||
| CHI Memorial Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects were underwent baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group. | Posted | Count of Participants | Participants | day of procedure |
Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure.
An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
This definition includes events related to:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment | VIRAL ILLNESS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment | Coughing up blood |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Bayliss | Medtronic | (763) 647-5547 | katie.j.bayliss@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Clinical Investigation Plan | Apr 9, 2018 | Feb 5, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2019 | Feb 5, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol: Clinical Investigation Plan Note to File | Dec 5, 2019 | Feb 5, 2020 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| Chattanooga |
| Tennessee |
| 37404 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Medical History | Number | participants |
|
| Lesion Characteristics | Lesion data is only available in subjects with local registration attempted. | Number | lesion |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | 2 of 49 cases did not complete local registration | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | minutes | 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 | Posted | Mean | Standard Deviation | Minutes | 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 | Four cases were considered technically successful but could not be analyzed due to inadequate video recording and an additional four technically successful cases had data from only FNAV/CBCT 1 (n=2) or only FNAV/CBCT 2 (n=2), resulting in evaluable datasets of 41 subjects per FNAV/CBCT group. | Posted | Median | Full Range | Minutes | day of procedure | Local Registrations | Local Registrations |
|
|
|
| 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". | ROSE was attempted in 49/49 cases. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Number | tool use | day of procedure |
|
|
|
| Secondary | Tool Order | Tool order analysis reports the number of times that a tool was used first in a patient. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | passes | 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. | Patients with overall malignant results by ROSE (26/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case. Bronchoalveolar Lavage is not applicable for ROSE. | Posted | Number | participants | 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. | Patients with overall malignant results by Pathology (30/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case. | Posted | Number | malignant results | 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. | 38 subjects had adequate video files to assess this endpoint | Posted | Count of Participants | Participants | 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. | 47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group. | Posted | Median | Full Range | 3D percent overlap | day of procedure |
|
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 7 |
| 50 |
|
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment | Tiny left apical pneumothorax noted on post-bronchoscopic x-ray |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment | Patient feeling lightheaded, but it was relieved with rest. |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment | Difficulty urinating |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment | Chronic obstructive pulmonary disease (COPD) Exacerbation, shortness of breath |
|
Institution/Investigator may publish the results of work performed under this Agreement, in accordance with the Publication Policy described in the Clinical Investigation Plan and publication guidelines from the Declaration of Helsinki. Institution and Investigator shall not publish the Study results until after Medtronic's Multi-site publication or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs first.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Cytology Brush |
|
| superDimension triple needle cytology brush |
|
| superDimension needle-tipped cytology brush |
|
| Bronchoalveolar lavage/washing |
|
| Title | Measurements |
|---|---|
|
| Cytology brush, superDimension |
|
|
| Cytology Brush |
|
|
| superDimension Needle-Tipped Cytology Brush |
|
|
| Gencut Core Biopsy Tool |
|
|
| superDimension Triple Needle Cytology Brush |
|
|
|
| Cytology Brush |
|
|
| superDimension Needle-Tipped Cytology Brush |
|
|
| Gencut Core Biopsy Tool |
|
|
| superDimension Triple Needle cytology Brush |
|
|
| Bronchoalveolar Lavage |
|
|