Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

Study Overview
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Brief Summary
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To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target location. 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.

Detailed Description
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Multi-center, prospective, single-arm study. The Study will take the form of a User Evaluation. The Evaluation will require the user to perform several standardized functions (e.g. peripheral lesion sampling, lymph node sampling). In addition, users will be asked about other potential techniques that fall within the intended use of the device. 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.

Official Title
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Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided Informed Consent 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: Patients less than 18 years of age. Any patient that the Investigator feels is not appropriate for this study for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchoscopy, lung neoplasm<br>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. | Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)<br>* 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.<br>* Other names: LungPoint Virtual Bronchoscopic Navigation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures |  | Immediate post-operative (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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navigation, bronchoscopy, lymphadenopathy