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Evaluation of a New Open Source Virtual Bronchoscope Navigation System

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ClinicalTrials.gov Identifier: NCT03745859
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
SINTEF Health Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bronchial Neoplasms Device: Fraxinus VBN system

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Intervention Details:
  • Device: Fraxinus VBN system
    Open source planning tool for bronchoscopy
    Other Name: Virtual Bronchoscopic Navigation System


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Diagnostic yield [ Time Frame: 1 week ]
    Diagnostic success defined as cytology or biopsy with pathology

  2. Duration of procedure [ Time Frame: 48 hours ]
    Time spent with preparations and bronchoscopy

  3. Adverse events [ Time Frame: 48 hours ]
    Procedure related adverse events or unexpected incidents registrated

  4. Operators-reported satisfaction [ Time Frame: 48 hours ]
    Enquiry on main operator´s experience after end of bronchoscopy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patents with undiagnosed peripheral pulmonary lesion(s) who have been recommended for bronchoscopy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745859


Contacts
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Contact: Arne Kildahl-Andersen, md 72829988 arne.kildahl-andersen@stolav.no
Contact: Håkon O Leira, md phd hakon.o.leira@ntnu.no

Locations
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Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Arne Kildahl-Andersen       arne.kildahl-andersen@stolav.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
SINTEF Health Research
Investigators
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Study Director: Hanne Sorger, md phd Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03745859     History of Changes
Other Study ID Numbers: 2018/302
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Bronchoscopy
Navigation
Feasibility Studies

Additional relevant MeSH terms:
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Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Diseases
Respiratory Tract Diseases