Evaluation of a New Open Source Virtual Bronchoscope Navigation System

December 5, 2022 updated by: Norwegian University of Science and Technology

Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
Time Frame: 48 hours
The proportion of cases in which the use of the system is considered beneficial
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 1 week
Diagnostic success defined as cytology or biopsy with pathology
1 week
Duration of procedure
Time Frame: 48 hours
Time spent with preparations and bronchoscopy
48 hours
Adverse events
Time Frame: 48 hours
Procedure related adverse events or unexpected incidents registrated
48 hours
Operators-reported satisfaction
Time Frame: 48 hours
Enquiry on main operator´s experience after end of bronchoscopy
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
SINTEF Health Research

Investigators

  • Study Director: Hanne Sorger, md phd, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2018

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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