LungPoint ATV for Biopsy in Patients Undergoing Lobectomy (LABEL)
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|ClinicalTrials.gov Identifier: NCT02130115|
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: LungPoint ATV System||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LungPoint ATV for Biopsy in Patients Undergoing Lobectomy|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||December 2013|
- Device: LungPoint ATV System
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
- 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.
- Proportion of nodules biopsied yielding tissue sufficient for diagnosis [ Time Frame: Upon asssessment of histology of tissue sample taken during procedure ]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.
- Number of significant adverse events [ Time Frame: Up through lobectomy of lobe at end of procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130115
|Heidelberg, Germany, 69126|
|Principal Investigator:||Felix Herth, MD||Heidelberg University|