Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

NCT ID: NCT01067755

Last Updated: 2010-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Lung Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bronchoscopy, lung neoplasm

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.

LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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LungPoint Virtual Bronchoscopic Navigation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

Broncus Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Thoraxklinik, University of Heidelberg

Principal Investigators

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Felix Herth, MD, PhD, FCCP

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Thoraxklinik

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Felix Herth

Role: primary

References

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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.

Reference Type DERIVED
PMID: 20802352 (View on PubMed)

Other Identifiers

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Protocol 35

Identifier Type: -

Identifier Source: org_study_id

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