Evaluation of a New Open Source Virtual Bronchoscope Navigation System

Norwegian University of Science and Technology

Status: Terminated

Conditions: Bronchial Neoplasms

Treatments: Device: Fraxinus VBN system

Study type: Observational

Funder types: Other

Identifiers

NCT03745859

2018/302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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