Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
18 Years
N/A
Both
Lung Neoplasm
Trial Information
Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
Outcome Time Frame:
Immediate post-operative (day 0)
Safety Issue:
No
Principal Investigator
Felix Herth, MD, PhD, FCCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg
Authority:
Germany: Ethics Commission
Study ID:
Protocol 35
NCT ID:
NCT01067755
Start Date:
July 2009
Completion Date:
March 2011
Related Keywords:
- Lung Neoplasm
- navigation
- bronchoscopy
- lymphadenopathy
- Neoplasms
- Lung Neoplasms
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