Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
NCT ID: NCT01067755
Last Updated: 2010-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2009-07-31
2011-03-31
Brief Summary
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The evaluation will explore:
* Ability of the system to guide a user to one or more target site(s)
* Ease of use of the system (assessment of the user interface)
* Incremental value brought by the use of the system to the successful completion of a case.
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Detailed Description
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The evaluation will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of such patients include:
* Patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion.
* Patients who have been recommended for bronchoscopy for the purpose of diagnosing mediastinal or hilar lymphadenopathy.
* Patients who have been recommended for bronchoscopy for the purpose of lung fiducial placement.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Bronchoscopy, lung neoplasm
Patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion, diagnosing mediastinal or hilar lymphadenopathy or for lung fiducial placement.
LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)
LungPoint Virtual Bronchoscopic Navigation is a product that displays images and information to aid bronchoscopists in guiding the bronchoscope and other instruments to a target location in the lung airways.
Interventions
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LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)
LungPoint Virtual Bronchoscopic Navigation is a product that displays images and information to aid bronchoscopists in guiding the bronchoscope and other instruments to a target location in the lung airways.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is scheduled for bronchoscopy for the purpose of diagnosing: a central or peripheral pulmonary nodule or mass, infiltrative disease, mediastinal or hilar lymphadenopathy, or placing fiducial markers.
* Subject has a CT scan that is consistent with high-resolution specifications
Exclusion Criteria
* Any patient that the Investigator feels is not appropriate for this study for any reason.
18 Years
ALL
Yes
Sponsors
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Heidelberg University
OTHER
Broncus Technologies
INDUSTRY
Responsible Party
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Thoraxklinik, University of Heidelberg
Principal Investigators
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Felix Herth, MD, PhD, FCCP
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Thoraxklinik
Heidelberg, , Germany
Countries
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Facility Contacts
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References
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Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.
Other Identifiers
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Protocol 35
Identifier Type: -
Identifier Source: org_study_id
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