Lung Neoplasm Clinical Trial
Official title:
Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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