Lung CancerLABELNCT02130115
LungPoint ATV for Biopsy in Patients Undergoing Lobectomy
A study testing LungPoint ATV System in people with Lung Cancer, run by Broncus Medical Inc at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LungPoint ATV System
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical candidates age 21-75 years at screening
- Known or suspected lung cancer or intrapulmonary metastatic disease with SPN greater than 10 mm and less than 40mm in largest dimension
- No known endobronchial tumor
- Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE.
- Willing to participate in all aspects of study protocol for duration of study
- Able to understand study requirements
- Signs study-related informed consent document
Who cannot join
- Any contraindication to bronchoscopy, for example: (a.) Untreatable life-threatening arrhythmias, (b.) Inability to adequately oxygenate the patient during the procedure, (c.) Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated), (d.) Recent myocardial infarction, (e.) Previously diagnosed high-grade tracheal obstruction, (f.) Uncorrectable coagulopathy.
- Known coagulopathy
- Platelet dysfunction or platelet count < 100 x 103 cells/mm3
- History of major bleeding with bronchoscopy
- Pulmonary hypertension with mean PAP >25 mm
- Moderate-to-severe pulmonary fibrosis
Show all 17Show fewer
- Moderate to severe emphysema or COPD with FEV1 <60% predicted or RV >200% predicted
- Bullae >5 cm located in vicinity of target SPN or ATV tunnel
- Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example: (a.) ASA class > 3, (b.) > stage 3 heart failure, (c.) severe cachexia, (d.) severe respiratory insufficiency or hypoxia
- Ongoing systemic infection
- Contraindication to general anesthesia
- Chronic use of anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel)
- Participation in any other study in last 30 days
- Prior thoracic surgery on the same side of the lung as the SPN
- Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
- Life expectancy of less than one year.
- Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System.
Read the detailed description
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. This feasibility study is being conducted to assess the ability of the investigator to access and sample tissue using this system in patients undergoing lobectomy or pneumonectomy. Navigation to and sampling of the patient's lung cancer tumor is conducted immediately prior to the scheduled lobectomy or pneumonectomy.
Note: This study was conducted as a single-center feasibility clinical trial to determine the feasibility of this device. The primary outcome measures related only to feasibility and not to health outcomes. Therefore it was not registered on clinicaltrials.gov prior to the start of enrollment. Subsequently, it was determined that the results were compelling and therefore it was registered to facilitate publication.
- Conditions
- Lung Cancer
- Being tested
- LungPoint ATV System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungPoint ATV SystemDevice
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to complete procedure using system
The proportion of cases (attempted nodules) in which the procedure could be substantially completed by the investigator divided by the number of cases (nodules) for which at least one attempt to pass any LungPoint study device into the bronchoscope was made.
Measured: At completion of procedure
Secondary outcomes (2)
Proportion of nodules biopsied yielding tissue sufficient for diagnosis
The number of nodules with at least one biopsy sufficient for a tissue diagnosis divided by the number of nodules sampled using the LungPoint ATV system.
Measured: Upon asssessment of histology of tissue sample taken during procedure
Number of significant adverse events
The number of SAEs rated as probably or definitely related to the study device and/or procedure divided by the number of patients in whom an attempt at study device use was made. The adverse events specifically tracked in this study are hemoptysis and pneumothorax.
Measured: Up through lobectomy of lobe at end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionDec 2013
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 CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Broncus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Herth, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130115
- Sponsor's protocol ID
- Protocol 40
- Acronym
- LABEL
- Status last verified
- May 2014
- First submitted
- 25 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015 Apr;70(4):326-32. doi: 10.1136/thoraxjnl-2014-206211. Epub 2015 Mar 6.
PubMed 25746631
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LungPoint ATV for Biopsy in Patients Undergoing Lobectomy
- ClinicalTrials.gov ID
- NCT02130115
- Acronym / sponsor ID
- LABEL / Protocol 40
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Broncus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 May 2014 (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.
The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System.
Detailed description
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. This feasibility study is being conducted to assess the ability of the investigator to access and sample tissue using this system in patients undergoing lobectomy or pneumonectomy. Navigation to and sampling of the patient's lung cancer tumor is conducted immediately prior to the scheduled lobectomy or pneumonectomy.
Note: This study was conducted as a single-center feasibility clinical trial to determine the feasibility of this device. The primary outcome measures related only to feasibility and not to health outcomes. Therefore it was not registered on clinicaltrials.gov prior to the start of enrollment. Subsequently, it was determined that the results were compelling and therefore it was registered to facilitate publication.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Surgical candidates age 21-75 years at screening
- Known or suspected lung cancer or intrapulmonary metastatic disease with SPN greater than 10 mm and less than 40mm in largest dimension
- No known endobronchial tumor
- Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE.
- Willing to participate in all aspects of study protocol for duration of study
Key exclusion criteria (17 listed)
- Any contraindication to bronchoscopy, for example: (a.) Untreatable life-threatening arrhythmias, (b.) Inability to adequately oxygenate the patient during the procedure, (c.) Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated), (d.) Recent myocardial infarction, (e.) Previously diagnosed high-grade tracheal obstruction, (f.) Uncorrectable coagulopathy.
- Known coagulopathy
- Platelet dysfunction or platelet count < 100 x 103 cells/mm3
- History of major bleeding with bronchoscopy
- Pulmonary hypertension with mean PAP >25 mm
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 ATV SystemThe LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. | Device | – |
Primary outcome
Ability to complete procedure using system
Time frame: At completion of procedure
The proportion of cases (attempted nodules) in which the procedure could be substantially completed by the investigator divided by the number of cases (nodules) for which at least one attempt to pass any LungPoint study device into the bronchoscope was made.
2 secondary outcomes
Proportion of nodules biopsied yielding tissue sufficient for diagnosis
Time frame: Upon asssessment of histology of tissue sample taken during procedure
Number of significant adverse events
Time frame: Up through lobectomy of lobe at end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Derived from this study: PubMed 25746631Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015 Apr;70(4):326-32. doi: 10.1136/thoraxjnl-2014-206211. Epub 2015 Mar 6.
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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 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?
A study testing LungPoint ATV System in people with Lung Cancer, run by Broncus Medical Inc 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 5 May 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to complete procedure using system (time frame: At completion of procedure). 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 NCT02130115, 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 5 May 2014.