Lung Lesion(s) Requiring EvaluationNCT02410837
NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
An observational study of Lung Lesion(s) Requiring Evaluation, run by Medtronic - MITG at 37 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Lesion(s) Requiring Evaluation
- What is being tested?
- Electromagnetic Navigation Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,388 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 16 Apr 2015to 1 Nov 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.
Who may be able to join
- Subject presents with lung lesion(s) requiring evaluation
- Subject is willing and able to provide informed consent to participate in the study
- Subject is candidate for elective ENB™ procedure
- Subject is over the age of 18
Who cannot join
- 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
37 sites in 7 countries.
37 sites in 7 countries
United States29 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
Seton Medical Center Austin
Austin, Texas, 78701
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, 33511
Charleston Area Medical Center
Charleston, West Virginia, 25304
Carolina's Healthcare System
Charlotte, North Carolina, 28207
Pulmonary Medicine Center of Chattanooga - Memorial Health
Chattanooga, Tennessee, 37404
The University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Physicians Company LLC
Cincinnati, Ohio, 45206
University Hospitals of Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Penn Highlands Healthcare
DuBois, Pennsylvania, 15801
Duke University
Durham, North Carolina, 27705
Inova Fairfax Hospital
Falls Church, Virginia, 22042
East Carolina University
Greenville, North Carolina, 27834
Gundersen Lutheran Medical Foundation, Inc
La Crosse, Wisconsin, 54601
Virtua Medical Group, PA
Marlton, New Jersey, 08053
Blount Memorial Hospital
Maryville, Tennessee, 37804
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 35294
Palo Alto Medical Foundation
Mountain View, California, 94040
Vanderbilt University
Nashville, Tennessee, 37235
Cancer Treatment Centers of America
Newnan, Georgia, 30265
Ocala Lung and Critical Care
Ocala, Florida, 34471
Pinehurst Medical Center
Pinehurst, North Carolina, 28374
UPMC - Shadyside Medical Center
Pittsburgh, Pennsylvania, 15232
University of Rochester
Rochester, New York, 14627
East Texas Medical Center
Tyler, Texas, 75701
Providence Health Center
Waco, Texas, 76712
Italy2 sites
Azienda Ospedaliero Universitaria Careggi
Florence
IRCCS Azienda Ospedaliera Universitaria San Martino - IST
Genova, 16132
About this study
The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Lung Lesion(s) Requiring Evaluation
- Being tested
- Electromagnetic Navigation Bronchoscopy
- Keywords
- lung lesion, biopsy, bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Navigation BronchoscopyProcedure or surgery
Also called ENB, superDimension
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pneumothorax (Grade 2+)
The primary endpoint is the incidence of pneumothorax related to the ENB™ index procedure rated as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) scale.
Pneumothorax is a disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung.
Severity increases as grade increases. Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis); Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death
Measured: index procedure visit
Secondary outcomes (18)
Incidence of Pneumothorax (All)
The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.
Measured: index procedure visit
Incidence of Bronchopulmonary Hemorrhage
The incidence of bronchopulmonary hemorrhage (rated as Grade 2 or higher according to th CTCAE scale) related to all ENB™ index procedures will be evaluated.
Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
Severity increases as grade increases. Grade 1: Mild symptoms; intervention not indicated; Grade 2: Moderate symptoms; medical intervention indicated; Grade 3: Transfusion, radiologic, endoscopic, or operative intervention indicated (e.g., hemostasis of bleeding site); Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated; Grade 5: Death
Measured: index procedure visit
Incidence of Respiratory Failure
The incidence of respiratory failure (rated as Grade 4 or higher according to the CTCAE scale) related to all ENB™ index procedures will be evaluated.
A respiratory failure is a disorder characterized by impaired gas exchange by the respiratory system resulting in hypoxemia and a decrease in oxygenation of the tissues that may be associated with an increase in arterial levels of carbon dioxide.
Severity increases as grade increases. Within CTCAE, there are no grades 1, 2, or 3 for Respiratory Failure.
Grade 4: Life-threatening consequences; urgent intervention, intubation, or ventilatory support indicated; Grade 5: Death
Measured: index procedure visit
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)
Subject health status evaluated by EuroQol-5d (EQ-5D) questionnaire at all visits. (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health state) Questionnaire from EuroQol Group. Outcome reported on overall health state over time. 0 = worst imaginable health state, 100 = best imaginable health state.
Measured: Baseline, 1 month, 12 month, and 24 month follow up visits
Subject Satisfaction
Subject satisfaction evaluation at the 1 month visit.
The question was "overall, how satisfied were you with the ENB procedure". Options were:
- Totally Dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- Extremely Satisfied
Measured: at the 1 month follow up visit
Subject Productivity and Activity
Electromagnetic Navigation Bronchoscopy (ENB) procedure effect on subject productivity and activity using the ENB Productivity and Activity Questionnaire (ENB-PAQ) will be evaluated.
The outcome measurement is the effect of ENB on their regular daily activities on a scale of 0-10 (0=no effect, 10=completely prevented).
Measured: at the 1 month follow up visit
Diagnostic Yield
Diagnostic yield will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion.
Diagnostic yield was calculated per subject as the rate of true positives (TP) (for malignancy) plus true negatives (TN) (for malignancy) out of all subjects with attempted lung lesion biopsies (the denominator included subjects with no tissue obtained due to unsuccessful navigation).
Measured: up to 24 months
Sensitivity
Sensitivity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other lung diseases in a lung lesion. [True Positives =TP, False Negatives = FN].
(TP / [TP+FN])
Measured: up to 24 months
Specificity
Specificity will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Positives = FN] (TN / [FP+TN])
Measured: up to 24 months
Positive Predictive Value
Positive predictive value (PPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Positives = TP, False Positives = FP] (TP / [TP+FP])
Measured: up to 24 months
Negative Predictive Value
Negative Predictive Value (NPV) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. [True Negatives = TN, False Negatives = FN] (TN / [FN+TN])
Measured: up to 24 months
Repeat Biopsy Rate
Repeat biopsy rate due to lack of diagnosis during the ENB™ index procedure will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion.
Measured: up to 24 months
Tissue Adequacy for Molecular Genetic Testing
Tissue adequacy for molecular genetic testing (if applicable).
Measured: at index procedure visit
Diagnosis
Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)
Measured: up to 24 months
Stage at Diagnosis
Stage at diagnosis (if applicable) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion. (Diagnosis worsens as stage number increases).
Refer to the American Joint Committee on Cancer, 7th edition on Lung Cancer Staging. A brief description is provided here.
Stage I = small lesions, no lymph node involvement Stage II = larger lesions and/or lymph nodes on sides of lung involved Stage III = larger lesions and/or lymph nodes in middle of chest involved Stage IV = metastases to other organs
Measured: up to 24 months
Success Rate of Accurate Placement of Fiducial Markers
The success rate of accurate placement of fiducial markers demonstrated through follow up imaging will be evaluated for all ENB™ index procedures conducted for placement of fiducial markers.
Measured: at index procedure visit
Success Rate of Dye Marking
The success rate of dye marking demonstrated by successful surgical resection will be evaluated for all ENB™ index procedures conducted for dye marking in preparation for surgical resection.
Measured: at index procedure visit
Success Rate of Obtaining Lymph Node Biopsy
The success rate of obtaining a lymph node biopsy to provide the stage of diagnosis will be evaluated for all ENB™ index procedures conducted for a lymph node biopsy.
Measured: at index procedure visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start16 Apr 2015
- Primary completion1 Nov 2019
- Study completion1 Nov 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Lesion(s) Requiring EvaluationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,388 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Khandhar, MD, Principal investigator, Inova Fairfax HospitalErik Folch, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410837
- Sponsor's protocol ID
- COVENBP0475
- Status last verified
- May 2021
- First submitted
- 31 Mar 2015
- Last updated
- 10 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Sarnaik KS, Linden PA, Gasnick A, Bassiri A, Manyak GA, Jarrett CM, Sinopoli JN, Tapias Vargas L, Towe CW. Computational risk model for predicting 2-year malignancy of pulmonary nodules using demographic and radiographic characteristics. J Thorac Cardiovasc Surg. 2024 Jun;167(6):1910-1924.e2. doi: 10.1016/j.jtcvs.2023.09.027. Epub 2023 Sep 17.
PubMed 37717851Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.
PubMed 30958102Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.
PubMed 28399830Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y.
PubMed 27113209
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
- ClinicalTrials.gov ID
- NCT02410837
- Acronym / sponsor ID
- COVENBP0475
- Conditions
- Lung Lesion(s) Requiring Evaluation
- Keywords
- lung lesion, biopsy, bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 11 Mar 2021
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 study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.
Key inclusion criteria (4 listed)
- Subject presents with lung lesion(s) requiring evaluation
- Subject is willing and able to provide informed consent to participate in the study
- Subject is candidate for elective ENB™ procedure
- Subject is over the age of 18
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| Electromagnetic Navigation BronchoscopyAlso: ENB, superDimension | Procedure or surgery | – |
Primary outcome
Incidence of Pneumothorax (Grade 2+)
Time frame: index procedure visit
The primary endpoint is the incidence of pneumothorax related to the ENB™ index procedure rated as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) scale. Pneumothorax is a disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung. Severity increases as grade increases. Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis); Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death
18 secondary outcomes
Incidence of Pneumothorax (All)
Time frame: index procedure visit
Incidence of Bronchopulmonary Hemorrhage
Time frame: index procedure visit
Incidence of Respiratory Failure
Time frame: index procedure visit
Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)
Time frame: Baseline, 1 month, 12 month, and 24 month follow up visits
Subject Satisfaction
Time frame: at the 1 month follow up visit
Subject Productivity and Activity
Time frame: at the 1 month follow up visit
Diagnostic Yield
Time frame: up to 24 months
Sensitivity
Time frame: up to 24 months
Specificity
Time frame: up to 24 months
Positive Predictive Value
Time frame: up to 24 months
Negative Predictive Value
Time frame: up to 24 months
Repeat Biopsy Rate
Time frame: up to 24 months
Tissue Adequacy for Molecular Genetic Testing
Time frame: at index procedure visit
Diagnosis
Time frame: up to 24 months
Stage at Diagnosis
Time frame: up to 24 months
Success Rate of Accurate Placement of Fiducial Markers
Time frame: at index procedure visit
Success Rate of Dye Marking
Time frame: at index procedure visit
Success Rate of Obtaining Lymph Node Biopsy
Time frame: at index procedure visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37717851Sarnaik KS, Linden PA, Gasnick A, Bassiri A, Manyak GA, Jarrett CM, Sinopoli JN, Tapias Vargas L, Towe CW. Computational risk model for predicting 2-year malignancy of pulmonary nodules using demographic and radiographic characteristics. J Thorac Cardiovasc Surg. 2024 Jun;167(6):1910-1924.e2. doi: 10.1016/j.jtcvs.2023.09.027. Epub 2023 Sep 17.
- Derived from this study: PubMed 30958102Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.
- Derived from this study: PubMed 28399830Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.
- Derived from this study: PubMed 27113209Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y.
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.
Sandeep Khandhar, MD principal investigator
Inova Fairfax Hospital
Erik Folch, MD principal investigator
Massachusetts General Hospital
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Lesion(s) Requiring Evaluation, run by Medtronic - MITG at 37 sites in 7 countries.
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 4 inclusion and 3 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Austria, Italy, Denmark, France and 2 more countries. 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 11 Mar 2021). 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?
Incidence of Pneumothorax (Grade 2+) (time frame: index procedure visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410837, which also lists 4 linked publications.
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 10 May 2021.