Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Archimedes System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-75 years at screening Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension No known endobronchial tumor Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE. Willing to participate in all aspects of study protocol for duration of study Able to understand study requirements Subject or legally authorized representative signs study-related informed consent document Exclusion Criteria: 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 Known coagulopathy Platelet dysfunction or platelet count < 100 x 103 cells/mm3 History of major bleeding with bronchoscopy Suspected pulmonary hypertension: additional testing required, such as echocardiogram Moderate-to-severe pulmonary fibrosis Severe emphysema or COPD: additional testing and PI consent is required Bullae >5 cm located in vicinity of target nodule or tunnel 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 Ongoing systemic infection Contraindication to general anesthesia Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure Participation in any other study in last 30 days Prior thoracic surgery on the same side of the lung as the SPN. 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. Life expectancy of less than one year. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy Prior radiation therapy treatment in the target lobe

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: -Navigation and tissue sampling<br>Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System | Device: Archimedes System<br>* The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of biopsies yielding tissue sufficient for diagnosis | The number of nodules with at least one biopsy sufficient for a definitive tissue diagnosis divided by the number of nodules sampled by the Archimedes System. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure planning time | The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported | Up to 1 year | 
| Nodule access time | The time from the start of navigation until the sheath has been placed at the first biopsy target. | Up to 1 year | 
| Fluoroscopy time | The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry. | Up to 1 year | 
| Patient registration time | The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system. | Up to 1 year |