The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.
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 Type
OBSERVATIONAL
Enrollment
1,388
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
Time frame: index procedure visit
Incidence of Pneumothorax (All)
The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.
Time frame: 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
Time frame: 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
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
Palo Alto Medical Foundation
Mountain View, California, United States
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, United States
Ocala Lung and Critical Care
Ocala, Florida, United States
Cancer Treatment Centers of America
Newnan, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Virtua Medical Group, PA
Marlton, New Jersey, United States
...and 27 more locations
Time frame: 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.
Time frame: 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: 1. Totally Dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Time frame: 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).
Time frame: 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).
Time frame: 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 / \[TP+FN\])
Time frame: 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 / \[FP+TN\])
Time frame: 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 / \[TP+FP\])
Time frame: 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 / \[FN+TN\])
Time frame: 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.
Time frame: up to 24 months
Tissue Adequacy for Molecular Genetic Testing
Tissue adequacy for molecular genetic testing (if applicable).
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at index procedure visit