Clinical trial · Interventional
Continuing Evaluation of the LungPoint ATV System
NCT02130128CI-TRIAL-00018206terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sufficient clinical evidence was gathered
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LungPoint ATV System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Navigation and tissue sampling
- description
- Guided bronchoscopic navigation and lung tissue sampling using the LungPoint ATV System
- interventionNames
- Device: LungPoint ATV System
Primary outcomes (1)
- measure
- Number of serious adverse events
- timeFrame
- Up to 24 hours post procedure
- description
- 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 outcomes (1)
- measure
- Proportion of biopsies yielding tissue sufficient for diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.