Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

February 10, 2010 updated by: Broncus Technologies

Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • LungPoint Virtual Bronchoscopic Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
Time Frame: Immediate post-operative (day 0)
Immediate post-operative (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Broncus Technologies

Collaborators

Heidelberg University

Investigators

  • Principal Investigator: Felix Herth, MD, PhD, FCCP, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

March 1, 2011

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (ESTIMATE)

February 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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