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Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Broncus Technologies.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Heidelberg
Information provided by:
Broncus Technologies
ClinicalTrials.gov Identifier:
NCT01067755
First received: January 29, 2010
Last updated: February 10, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention
Lung Neoplasm
 Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Broncus Technologies:

Primary Outcome Measures:
  • Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures [ Time Frame: Immediate post-operative (day 0) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Heidelberg
Investigators
Principal Investigator: Felix Herth, MD, PhD, FCCP University of Heidelberg
  More Information

No publications provided by Broncus Technologies

Additional 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
Study First Received: January 29, 2010
Last Updated: February 10, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Broncus Technologies:
navigation
bronchoscopy
lymphadenopathy

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

ClinicalTrials.gov processed this record on May 16, 2013