Lung NeoplasmNCT01067755
Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
An observational study of Lung Neoplasm, run by Broncus Technologies at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients less than 18 years of age.
- Any patient that the Investigator feels is not appropriate for this study for any reason.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik
Heidelberg
Felix Herth, Felix.Herth@thoraxklinik-heidelberg.de
Felix JF Herth, MD, PhD, FCCP
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Neoplasm
- Being tested
- LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)
- Keywords
- navigation, bronchoscopy, lymphadenopathy
- Medical subject headings
- Lung Neoplasms, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)Device
Also called LungPoint Virtual 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
Measured: Immediate post-operative (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Broncus Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heidelberg University
- Investigators
- Felix Herth, MD, PhD, FCCP, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067755
- Sponsor's protocol ID
- Protocol 35
- Status last verified
- Feb 2010
- First submitted
- 29 Jan 2010
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20802352
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
- ClinicalTrials.gov ID
- NCT01067755
- Acronym / sponsor ID
- Protocol 35
- Conditions
- Lung Neoplasm
- Keywords
- navigation, bronchoscopy, lymphadenopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Broncus TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Heidelberg University
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy, lung neoplasm | – | Device: LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients less than 18 years of age.
- Any patient that the Investigator feels is not appropriate for this study for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)Also: LungPoint Virtual Bronchoscopic NavigationLungPoint 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. | Device | Bronchoscopy, lung neoplasm |
Primary outcome
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
Time frame: Immediate post-operative (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
- Derived from this study: PubMed 20802352Eberhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Herth, MD, PhD, FCCP principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by Broncus Technologies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures (time frame: Immediate post-operative (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2010.