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The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungPoint ATV System | Device | The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upon asssessment of histology of tissue sample taken during procedure |
| Number of significant adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Herth, MD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik | Heidelberg | 69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25746631 | Derived | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
| Up through lobectomy of lobe at end of procedure |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |