Evaluation of a New Open Source Virtual Bronchoscope Navigation System

Bronchial Neoplasms Clinical Trial

Official title:

Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03745859
• Other study ID #: 2018/302
• Status: Suspended
• Start date: November 19, 2018
• Est. completion date: October 2023

Study information

• Verified date: December 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Neoplasms

Intervention

Device:
• Fraxinus VBN system
Open source planning tool for bronchoscopy

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions	The proportion of cases in which the use of the system is considered beneficial	48 hours
Secondary	Diagnostic yield	Diagnostic success defined as cytology or biopsy with pathology	1 week
Secondary	Duration of procedure	Time spent with preparations and bronchoscopy	48 hours
Secondary	Adverse events	Procedure related adverse events or unexpected incidents registrated	48 hours
Secondary	Operators-reported satisfaction	Enquiry on main operator´s experience after end of bronchoscopy	48 hours