Lung Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer.
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 safety and yield of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer. Navigation to and sampling of the patient's lung cancer tumor is conducted.
Interventions
DEVICELungPoint ATV System
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
Sponsors
Broncus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Surgical candidates age 21-75 years at screening 2. Highly suspicious SPN, defined as distinct nodule with a diameter of 10-30 mm in its largest dimension 3. No known endobronchial tumor 4. Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE. 5. Willing to participate in all aspects of study protocol for duration of study 6. Able to understand study requirements 7. Signs study-related informed consent document
Exclusion criteria
1. 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. 2. Known coagulopathy 3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3 4. History of major bleeding with bronchoscopy 5. Pulmonary hypertension with mean PAP \>25 mm 6. Moderate-to-severe pulmonary fibrosis 7. Moderate to severe emphysema or COPD with FEV1 \<60% predicted or RV \>200% predicted 8. Bullae \>5 cm located in vicinity of target SPN or ATV tunnel 9. 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 10. Ongoing systemic infection 11. Contraindication to general anesthesia 12. Chronic use of anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) 13. Participation in any other study in last 30 days 14. Prior thoracic surgery on the same side of the lung as the SPN 15. 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. 16. Life expectancy of less than one year. 17. Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors 18. Scheduled for lung surgery within 7 days post-scheduled diagnostic bronchoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events | Up to 24 hours post procedure | The number of serious adverse events (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. This study protocol focuses specifically on sub-chronic pneumothorax, but will also track hemoptysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of biopsies yielding tissue sufficient for diagnosis | 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 by the LP ATV System. |
Countries
Germany
Outcome results
None listed