Clinical trial NCT02130128: Continuing Evaluation of the LungPoint ATV System
Official title: Continuing Evaluation of the LungPoint ATV System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Broncus Medical Inc
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of serious adverse events
timeFrame: Up to 24 hours post procedure
Secondary outcomes:
measure: Proportion of biopsies yielding tissue sufficient for diagnosis
timeFrame: Upon asssessment of histology of tissue sample taken during procedure
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
affiliation: Heidelberg University
name: Felix Herth, MD
role: PRINCIPAL_INVESTIGATOR
References: