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Trial record 1 of 1 for:    NCT02410837
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NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

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ClinicalTrials.gov Identifier: NCT02410837
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : March 11, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

Condition or disease Intervention/treatment
Lung Lesion(s) Requiring Evaluation Procedure: Electromagnetic Navigation Bronchoscopy

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.)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1388 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Actual Study Start Date : April 16, 2015
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019

Intervention Details:
  • Procedure: Electromagnetic Navigation Bronchoscopy
    Other Names:
    • ENB
    • superDimension


Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Incidence of Pneumothorax (All) [ Time Frame: index procedure visit ]
    The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.

  2. Incidence of Bronchopulmonary Hemorrhage [ Time Frame: index procedure visit ]

    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


  3. Incidence of Respiratory Failure [ Time Frame: index procedure visit ]

    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


  4. 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 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.

  5. Subject Satisfaction [ Time Frame: at the 1 month follow up visit ]

    Subject satisfaction evaluation at the 1 month visit.

    The question was "overall, how satisfied were you with the ENB procedure". Options were:

    1. Totally Dissatisfied
    2. Dissatisfied
    3. Neutral
    4. Satisfied
    5. Extremely Satisfied

  6. Subject Productivity and Activity [ Time Frame: at the 1 month follow up visit ]

    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).


  7. Diagnostic Yield [ Time Frame: up to 24 months ]

    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).


  8. Sensitivity [ Time Frame: up to 24 months ]

    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])


  9. Specificity [ Time Frame: up to 24 months ]
    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])

  10. Positive Predictive Value [ Time Frame: up to 24 months ]
    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])

  11. Negative Predictive Value [ Time Frame: up to 24 months ]
    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])

  12. Repeat Biopsy Rate [ Time Frame: up to 24 months ]
    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.

  13. Tissue Adequacy for Molecular Genetic Testing [ Time Frame: at index procedure visit ]
    Tissue adequacy for molecular genetic testing (if applicable).

  14. Diagnosis [ Time Frame: up to 24 months ]
    Diagnosis will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion (per subject)

  15. Stage at Diagnosis [ Time Frame: up to 24 months ]

    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


  16. Success Rate of Accurate Placement of Fiducial Markers [ Time Frame: at index procedure visit ]
    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.

  17. Success Rate of Dye Marking [ Time Frame: at index procedure visit ]
    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.

  18. Success Rate of Obtaining Lymph Node Biopsy [ Time Frame: at index procedure visit ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects that meet the various inclusion/exclusion criteria will be enrolled consecutively by each participating site.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02410837


Locations
Show Show 37 study locations
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Sandeep Khandhar, MD Inova Fairfax Hospital
Principal Investigator: Erik Folch, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02410837    
Other Study ID Numbers: COVENBP0475
First Posted: April 8, 2015    Key Record Dates
Results First Posted: March 11, 2021
Last Update Posted: May 10, 2021
Last Verified: May 2021
Keywords provided by Medtronic - MITG:
lung lesion
biopsy
bronchoscopy