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Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

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ClinicalTrials.gov Identifier: NCT01067755
Recruitment Status : Unknown
Verified February 2010 by Broncus Technologies.
Recruitment status was:  Recruiting
First Posted : February 12, 2010
Last Update Posted : February 12, 2010
Sponsor:
Collaborator:
Heidelberg University
Information provided by:
Broncus Technologies

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.

Condition or disease Intervention/treatment
Lung Neoplasm Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
Study Start Date : July 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
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.
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.
Other Name: LungPoint Virtual Bronchoscopic Navigation




Primary Outcome Measures :
  1. Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures [ Time Frame: Immediate post-operative (day 0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067755


Locations
Germany
Thoraxklinik Recruiting
Heidelberg, Germany
Contact: Felix Herth       Felix.Herth@thoraxklinik-heidelberg.de   
Principal Investigator: Felix JF Herth, MD, PhD, FCCP         
Sponsors and Collaborators
Broncus Technologies
Heidelberg University
Investigators
Principal Investigator: Felix Herth, MD, PhD, FCCP Heidelberg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med Felix Herth, Chief Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01067755     History of Changes
Other Study ID Numbers: Protocol 35
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: February 12, 2010
Last Verified: February 2010

Keywords provided by Broncus Technologies:
navigation
bronchoscopy
lymphadenopathy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases