Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| -Navigation and tissue sampling | Experimental | Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Archimedes System | Device | The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any contraindication to bronchoscopy, for example:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Duke University |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Cancer Treatment Centers of America at Southwestern Regional Medical Center | Tulsa | Oklahoma | 74133 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | China |
| ThoraxKlinik | Heidelberg | Germany |
| Hong Kong Sanatorium & Hospital | Hong Kong | Hong Kong |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |