NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

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

Detailed Description
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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.)

Official Title
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NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

Conditions
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Lung Lesion(s) Requiring Evaluation

Intervention / Treatment
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* Procedure: Electromagnetic Navigation Bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Electromagnetic Navigation Bronchoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | index procedure visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pneumothorax (All) | The incidence of pneumothorax related to all ENB™ index procedures will be evaluated. | 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 | 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 | 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. | 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 | 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). | 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). | 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]) | 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]) | 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]) | 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]) | 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. | up to 24 months | 
| Tissue Adequacy for Molecular Genetic Testing | Tissue adequacy for molecular genetic testing (if applicable). | 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) | 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 | 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. | 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. | 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. | at index procedure visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, lung lesion, bronchoscopy