Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Lung Cancer Clinical Trial

— EAST2  

Official title:

Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867371
• Other study ID #: Protocol 44
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2019
• Source: Broncus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 21-75 years at screening

2. Highly suspicious pulmonary nodule(s), 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. Subject or legally authorized representative signs study-related informed consent document

Exclusion Criteria:

1. Any contraindication to bronchoscopy, for example:

1. Untreatable life-threatening arrhythmias

2. Inability to adequately oxygenate the patient during the procedure

3. Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)

4. Recent myocardial infarction

5. Previously diagnosed high-grade tracheal obstruction

6. 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 nodule or tunnel

9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:

1. ASA class > 3

2. > stage 3 heart failure

3. severe cachexia

4. 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. Prior radiation therapy treatment in the target lobe

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Archimedes System
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Shanghai Chest Hospital	Shanghai	Shanghai
Germany	ThoraxKlinik	Heidelberg
Hong Kong	Hong Kong Sanatorium & Hospital	Hong Kong
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Duke University	Durham	North Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Cancer Treatment Centers of America at Southwestern Regional Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Broncus Medical Inc

Countries where clinical trial is conducted

United States,  China,  Germany,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure planning time	The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported	Up to 1 year
Secondary	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
Secondary	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
Secondary	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