Lung Neoplasm Clinical Trial
Official title:
Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
Verified date | February 2010 |
Source | Broncus Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Thoraxklinik | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
Broncus Technologies | Heidelberg University |
Germany,
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 |
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