Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

• Conditions: Lung Neoplasm
• Interventions: Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)

• Registration Number: NCT01067755
• Lead Sponsor: Broncus Technologies

Brief 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-01-29
• Status Verified: 2010-02
• Study First Submitted QC: 2010-02-10
• Last Update Submitted: 2010-02-10
• Study First Posted: 2010-02-12
• Last Update Posted: 2010-02-12
• Primary Completion: 2011-01
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchoscopy, lung neoplasm	LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)	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.

Primary Outcome Measures

Name	Time	Method
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures	Immediate post-operative (day 0)

Trial Locations

Locations (1)

Thoraxklinik; 🇩🇪 Heidelberg, Germany