Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2 (EAST2)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Archimedes System

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital
• Germany
  • Heidelberg, Germany
    • Thoraxklinik
• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Sanatorium & Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America at Southwestern Regional Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Broncus Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Protocol 44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No