NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
- Conditions
- Lung Lesion(s) Requiring Evaluation
- Registration Number
- NCT02410837
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1388
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Pneumothorax (Grade 2+) 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
Name Time Method Positive Predictive Value 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 / \[TP+FP\])
Incidence of Pneumothorax (All) index procedure visit The incidence of pneumothorax related to all ENB™ index procedures will be evaluated.
Incidence of Bronchopulmonary Hemorrhage 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: DeathQuality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) 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.
Sensitivity 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 / \[TP+FN\])Subject Satisfaction 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 SatisfiedSubject Productivity and Activity 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).Specificity 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 / \[FP+TN\])
Stage at Diagnosis 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 organsSuccess Rate of Dye Marking 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.
Incidence of Respiratory Failure 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: DeathDiagnostic Yield 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).Tissue Adequacy for Molecular Genetic Testing at index procedure visit Tissue adequacy for molecular genetic testing (if applicable).
Success Rate of Obtaining Lymph Node Biopsy 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.
Repeat Biopsy Rate 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.
Diagnosis 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)
Negative Predictive Value 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 / \[FN+TN\])
Success Rate of Accurate Placement of Fiducial Markers 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.
Trial Locations
- Locations (37)
Ocala Lung and Critical Care
🇺🇸Ocala, Florida, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Gundersen Lutheran Medical Foundation, Inc
🇺🇸La Crosse, Wisconsin, United States
Rigshospitalet - Copenhagen
🇩🇰Kobenhavn, Denmark
Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Pulmonary Associates of Mobile, P.C.
🇺🇸Mobile, Alabama, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Pinehurst Medical Center
🇺🇸Pinehurst, North Carolina, United States
University Hospitals of Case Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Penn Highlands Healthcare
🇺🇸DuBois, Pennsylvania, United States
UPMC - Shadyside Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Pulmonary Medicine Center of Chattanooga - Memorial Health
🇺🇸Chattanooga, Tennessee, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Cincinnati Physicians Company LLC
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Palo Alto Medical Foundation
🇺🇸Mountain View, California, United States
Salzburger Landesklinik (SALK)
🇦🇹Salzburg, Austria
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
University of Rochester
🇺🇸Rochester, New York, United States
Blount Memorial Hospital
🇺🇸Maryville, Tennessee, United States
Cancer Treatment Centers of America
🇺🇸Newnan, Georgia, United States
Pulmonary and Sleep of Tampa Bay
🇺🇸Brandon, Florida, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Carolina's Healthcare System
🇺🇸Charlotte, North Carolina, United States
AKH Linz
🇦🇹Linz, Austria
University Hospitals of Saint Etienne France
🇫🇷St. Etienne, France
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST
🇮🇹Genova, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
Seton Medical Center Austin
🇺🇸Austin, Texas, United States
Virtua Medical Group, PA
🇺🇸Marlton, New Jersey, United States