N/A
Completed N=1,388
NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Lung Lesion(s) Requiring Evaluation
Source: ClinicalTrials.gov NCT02410837 ↗
Enrolled (actual)
1,388
Serious AEs
35.8%
Results posted
Mar 2021
Primary outcomePrimary: Incidence of Pneumothorax (Grade 2+) — 44 Participants
Summary
The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Pneumothorax (Grade 2+) |
44 | — |
| SECONDARY Incidence of Pneumothorax (All) |
65 | — |
| SECONDARY Incidence of Bronchopulmonary Hemorrhage |
23 | — |
| SECONDARY Incidence of Respiratory Failure |
8 | — |
| SECONDARY Quality of Life (Mobility, Self-care, Activities, Pain/Discomfort, Anxiety/Depression, Health State) |
70.2; 69.2; 70.0; 72.6 | — |
| SECONDARY Subject Satisfaction |
4.4 | — |
| SECONDARY Subject Productivity and Activity |
0.9 | — |
| SECONDARY Diagnostic Yield |
822 | — |
| SECONDARY Sensitivity |
537 | — |
| SECONDARY Specificity |
285 | — |
| SECONDARY Positive Predictive Value |
537 | — |
| SECONDARY Negative Predictive Value |
285 | — |
| SECONDARY Repeat Biopsy Rate |
334 | — |
| SECONDARY Tissue Adequacy for Molecular Genetic Testing |
89 | — |
| SECONDARY Diagnosis |
279; 133; 16; 26; 17; 49 | — |
| SECONDARY Stage at Diagnosis |
251; 52; 81; 84 | — |
| SECONDARY Success Rate of Accurate Placement of Fiducial Markers |
253 | — |
| SECONDARY Success Rate of Dye Marking |
21 | — |
| SECONDARY Success Rate of Obtaining Lymph Node Biopsy |
31 | — |
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
Data sourced from ClinicalTrials.gov (NCT02410837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.