NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Lesion(s) Requiring Evaluation
- Sponsor
- Medtronic - MITG
- Enrollment
- 1388
- Locations
- 37
- Primary Endpoint
- Incidence of Pneumothorax (Grade 2+)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.)
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Positive Predictive Value(up to 24 months)
- Incidence of Pneumothorax (All)(index procedure visit)
- Incidence of Bronchopulmonary Hemorrhage(index procedure visit)
- Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State)(Baseline, 1 month, 12 month, and 24 month follow up visits)
- Sensitivity(up to 24 months)
- Subject Satisfaction(at the 1 month follow up visit)
- Subject Productivity and Activity(at the 1 month follow up visit)
- Specificity(up to 24 months)
- Stage at Diagnosis(up to 24 months)
- Success Rate of Dye Marking(at index procedure visit)
- Diagnostic Yield(up to 24 months)
- Incidence of Respiratory Failure(index procedure visit)
- Tissue Adequacy for Molecular Genetic Testing(at index procedure visit)
- Success Rate of Obtaining Lymph Node Biopsy(at index procedure visit)
- Repeat Biopsy Rate(up to 24 months)
- Diagnosis(up to 24 months)
- Negative Predictive Value(up to 24 months)
- Success Rate of Accurate Placement of Fiducial Markers(at index procedure visit)