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Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

2014-07-23 21:10:36 | BioPortfolio

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.

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Lung Neoplasm

Intervention

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

Location

Thoraxklinik
Heidelberg
Germany

Status

Recruiting

Source

Broncus Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:36-0400

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