Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchial Neoplasms
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
Brief Summary
To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.
Detailed Description
Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.
Investigators
Eligibility Criteria
Inclusion Criteria
- •referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy
- •voluntary signed an informed consent
Exclusion Criteria
- •pregnancy
- •Any patient that the Investigator feels is not appropriate for this study for any reason
Outcomes
Primary Outcomes
Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
Time Frame: 48 hours
The proportion of cases in which the use of the system is considered beneficial
Secondary Outcomes
- Adverse events(48 hours)
- Operators-reported satisfaction(48 hours)
- Duration of procedure(48 hours)
- Diagnostic yield(1 week)