Lung CancerNCT03585959
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
A study testing superDimension™ Navigation System Version 7.2 in people with Lung Cancer, run by Medtronic - MITG at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- superDimension™ Navigation System Version 7.2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2018to 18 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CHI Memorial Medical Group
Chattanooga, Tennessee, 37404
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
About this study
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
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- superDimension™ Navigation System Version 7.2
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superDimension™ Navigation System Version 7.2Device
superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: superDimension™ Navigation System Version 7.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day of procedure
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day of procedure
Tool Order
Tool order analysis reports the number of times that a tool was used first in a patient.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start3 Aug 2018
- Primary completion13 Feb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael A. Pritchett, DO MPH, Principal investigator, FirstHealth Moore Regional HospitalKrishnendu Bhadra, MD, Principal investigator, CHI Memorial Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585959
- Sponsor's protocol ID
- MDT18004ILSFNV
- Status last verified
- Apr 2020
- First submitted
- 21 Jun 2018
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03585959
- Acronym / sponsor ID
- MDT18004ILSFNV
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopic Navigation Arm | Experimental | Device: superDimension™ Navigation System Version 7.2An 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superDimension™ Navigation System Version 7.2superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy | Device | Fluoroscopic Navigation Arm |
Primary outcome
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.
16 secondary outcomes
Number of Cases That Are Technically Successful (Successful Completion of Local Registration)
Time frame: day of procedure
Number of Cases That Are Not Technically Successful (Local Registration Not Complete)
Time frame: day of procedure
Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.
Time frame: day of procedure
Total Procedure Time
Time frame: day of procedure
ENB Procedure Time
Time frame: day of procedure
Total Fluoroscopy Time
Time frame: day of procedure
Adequacy of the ENB-aided Tissue Sample
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)
Time frame: day of procedure
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
Biopsy Tools Used
Time frame: day of procedure
Tool Order
Time frame: day of procedure
Number of Tool Pases
Time frame: day of procedure
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
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
Percentage of Cases in Which the Intended Lesion is Correctly Identified
Time frame: day of procedure
Relational Accuracy in Cases in Which the Intended Lesion is Targeted
Time frame: day of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Pritchett, DO MPH principal investigator
FirstHealth Moore Regional Hospital
Krishnendu Bhadra, MD principal investigator
CHI Memorial Medical Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superDimension™ Navigation System Version 7.2 in people with Lung Cancer, run by Medtronic - MITG at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the Location Accuracy of the Local Registration Feature (time frame: day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.