Bronchial Neoplasms
Conditions
Keywords
Bronchoscopy, Navigation, Feasibility Studies
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.
Interventions
DEVICEFraxinus VBN system
Open source planning tool for bronchoscopy
Sponsors
St. Olavs Hospital
SINTEF Health Research
Norwegian University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions | 48 hours | The proportion of cases in which the use of the system is considered beneficial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 1 week | Diagnostic success defined as cytology or biopsy with pathology |
| Duration of procedure | 48 hours | Time spent with preparations and bronchoscopy |
| Adverse events | 48 hours | Procedure related adverse events or unexpected incidents registrated |
| Operators-reported satisfaction | 48 hours | Enquiry on main operator´s experience after end of bronchoscopy |
Countries
Norway
Outcome results
None listed