Clinical trial NCT01067755: Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
Official title: Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasm
Keywords: navigation
bronchoscopy
lymphadenopathy
Lead sponsor: Broncus Technologies
Sponsor class: INDUSTRY
Collaborators: name: Heidelberg University
First posted: 2010-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of those patient populations are:

* 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
timeFrame: Immediate post-operative (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
affiliation: Heidelberg University
name: Felix Herth, MD, PhD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.