Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01067755
• Other study ID #: Protocol 35
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2010
• Last updated: February 10, 2010
• Start date: July 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: Broncus Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Thoraxklinik	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Broncus Technologies	Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures		Immediate post-operative (day 0)	No