Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

NCT01067755 | Unknown

• 1 other identifier: Protocol 35
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm

Keywords

navigation; bronchoscopy; lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures

  Immediate post-operative (day 0)

Study Arms (1)

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)

Interventions

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

Also known as: LungPoint Virtual Bronchoscopic Navigation

Bronchoscopy, lung neoplasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients less than 18 years of age.
• Any patient that the Investigator feels is not appropriate for this study for any reason.

Sponsors & Collaborators

• Broncus Technologies: lead
• Heidelberg University: collaborator

Study Sites (1)

Thoraxklinik

Heidelberg, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 20802352 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lymphadenopathy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Felix Herth, MD, PhD, FCCP

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 12, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

DE (1)