NCT01067755

Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Broncus Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Lung Neoplasm

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2010-02-12
• Last updated: 2010-02-12

Locations

1 site across 1 country: Germany