Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

Broncus Medical

Status: Unknown

Conditions: Lung Neoplasm

Treatments: Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01067755

Protocol 35

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Bronchoscopy, lung neoplasm

Description:

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.

Treatment:

Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)