NCT03745859

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

November 15, 2018

Last Update Submit

June 20, 2025

Conditions

Bronchial Neoplasms

Keywords

BronchoscopyNavigationFeasibility Studies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Diagnostic yield

    1 week

  • Duration of procedure

    48 hours

  • Adverse events

    48 hours

  • Operators-reported satisfaction

    48 hours

Interventions

Fraxinus VBN systemDEVICE

Open source planning tool for bronchoscopy

Also known as: Virtual Bronchoscopic Navigation System

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patents with undiagnosed peripheral pulmonary lesion(s) who have been recommended for bronchoscopy

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • Any patient that the Investigator feels is not appropriate for this study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Bronchial Neoplasms

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsBronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Hanne Sorger, md phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

November 19, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

NO(1)