N/A
Completed N=50
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Source: ClinicalTrials.gov NCT03585959 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Apr 2020
Primary outcomePrimary: Confirm the Location Accuracy of the Local Registration Feature — 28; 19; 39; 8 Participants
Summary
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirm the Location Accuracy of the Local Registration Feature |
28; 19; 39; 8; 28; 13 | — |
| SECONDARY Number of Cases That Are Technically Successful (Successful Completion of Local Registration) |
47 | — |
| SECONDARY Number of Cases That Are Not Technically Successful (Local Registration Not Complete) |
2 | — |
| SECONDARY Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology. |
47 | — |
| SECONDARY Total Procedure Time |
65.3 | — |
| SECONDARY ENB Procedure Time |
54.3 | — |
| SECONDARY Total Fluoroscopy Time |
3.8 | — |
| SECONDARY Adequacy of the ENB-aided Tissue Sample |
49 | — |
| SECONDARY Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable) |
26; 23 | — |
| SECONDARY Final Pathology Results of the ENB-aided Tissue Sample |
30; 19 | — |
| SECONDARY Biopsy Tools Used |
42; 33; 10; 49; 2; 2 | — |
| SECONDARY Tool Order |
26; 23 | — |
| SECONDARY Number of Tool Pases |
6; 9; 2; 4 | — |
| SECONDARY Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample |
15; 2; 9; 2; 3; 1 | — |
| SECONDARY Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample |
21; 12; 20; 2; 5; 1 | — |
| SECONDARY Percentage of Cases in Which the Intended Lesion is Correctly Identified |
38; 0 | — |
| SECONDARY Relational Accuracy in Cases in Which the Intended Lesion is Targeted |
11.4; 32.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
- Lesion is intended to be biopsied by the participating investigator
- Subject is willing and able to provide informed consent to participate in the study
- Subject is a candidate for an elective ENB procedure
- Subject is over the age of 18
Exclusion Criteria
- Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
- Lesions within 10 mm of the diaphragm
- 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 (NCT03585959). 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.