Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02867371
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Broncus Medical Inc

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
Proportion of biopsies yielding tissue sufficient for diagnosis [ Time Frame: Up to 1 year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
Proportion of biopsies yielding tissue sufficient for diagnosis [ Time Frame: Up to 1 year ]
The 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Procedure planning time [ Time Frame: Up to 1 year ]
    The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported
  • Nodule access time [ Time Frame: Up to 1 year ]
    The time from the start of navigation until the sheath has been placed at the first biopsy target.
  • Fluoroscopy time [ Time Frame: Up to 1 year ]
    The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry.
  • Patient registration time [ Time Frame: Up to 1 year ]
    The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Official Title  ICMJE Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lung Cancer
Intervention  ICMJE Device: Archimedes System
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Study Arms  ICMJE Experimental: -Navigation and tissue sampling
Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System
Intervention: Device: Archimedes System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2019)
166
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
200
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Germany,   Hong Kong,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867371
Other Study ID Numbers  ICMJE Protocol 44
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Broncus Medical Inc
Study Sponsor  ICMJE Broncus Medical Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Broncus Medical Inc
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP