TerminatedNot applicableNCT02460120

Evaluation of the Archimedes™ System for Transparenchymal Nodule Access

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.

Checked against the public recordLast updated Jan 27, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhaseNot applicable
U.S. locations1
SponsorBroncus Medical Inc
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Broncus Medical Inc
Interventions being studied
Device: Archimedes System
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Age 21-75 years at screening 2. Highly suspicious SPN, defined as distinct nodule with a diameter of ≥8mm 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: * Untreatable life-threatening arrhythmias * Inability to adequately oxygenate the patient during the procedure * Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated) * Recent myocardial infarction * Previously diagnosed high-grade tracheal obstruction * Uncorrectable coagulopathy 2. Known coagulopathy 3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3 4. History of major bleeding with bronchoscopy 5. Suspected pulmonary hypertension: additional testing required, such as echocardiogram 6. Moderate-to-severe pulmonary fibrosis 7. Severe emphysema or COPD: additional testing and PI consent is required 8. Bullae \>5 cm located in vicinity of target SPN 9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example: * ASA class \> 3 * \> stage 3 heart failure * severe cachexia * severe respiratory insufficiency or hypoxia 10. Ongoing systemic infection 11. Contraindication to general anesthesia 12. Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure 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. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy 18. Pregnancy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cancer Treatment Centers of America at Southwestern Regional Medical CenterTulsa, Oklahoma

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 27, 2017. Always confirm current availability with the study team.

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