Evaluation of a New Open Source Virtual Bronchoscope Navigation System

Suspended

• Conditions: Bronchial Neoplasms

• Registration Number: NCT03745859
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study Start: 2018-11-19
• Study First Posted: 2018-11-19
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of procedure	48 hours	Time spent with preparations and bronchoscopy
Diagnostic yield	1 week	Diagnostic success defined as cytology or biopsy with pathology

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway