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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 : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : January 21, 2019
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

Study Type : Observational [Patient Registry]
Actual Enrollment : 1391 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™
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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


Primary Outcome Measures :
  1. Incidence of Pneumothorax (Grade 2+) [ Time Frame: up to 24 months ]
    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.


Secondary Outcome Measures :
  1. Incidence of Pneumothorax (All) [ Time Frame: up to 24 months ]
    The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.

  2. Incidence of Bronchopulmonary Hemorrhage [ Time Frame: up to 24 months ]
    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.

  3. Incidence of Respiratory Failure [ Time Frame: up to 24 months ]
    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.

  4. Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health state) [ Time Frame: at the 1 month, 12 month, and 24 month follow up visits ]
    Subject health status evaluated by EQ-5D questionnaire at all visits.

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

  6. Subject Productivity and Activity [ Time Frame: at the 1 month follow up visit ]
    ENB procedure effect on subject productivity and activity using the ENB Productivity and Activity Questionnaire (ENB-PAQ) will be evaluated.

  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.

  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.

  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.

  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.

  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.

  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) will be evaluated for all ENB™ index procedures performed for suspicion of cancer or other diseases in a lung lesion.

  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.

  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.

  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

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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


  Show 37 Study Locations
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Sandeep Khandhar, MD Inova Fairfax Hospital
Principal Investigator: Erik Folch, MD Massachusetts General Hospital