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

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ClinicalTrials.gov Identifier: NCT02867371
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Broncus Medical Inc

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Archimedes System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867371


Contacts
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Contact: Daniel Nader, D.O. 918-286-5000
Contact: Faye Biggs 918-286-5000

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Adnan Majid, M.D.    617-632-8386      
Contact: Alexis Agnew    617-632-8386      
Principal Investigator: Adnan Majid, M.D.         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Momen Wahidi, M.D.         
Contact: Moyinoluwa Adetunji    919-684-9139      
Principal Investigator: Momen Wahidi, M.D.         
United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Daniel Nader, D.O.    918-286-5000      
Contact: Faye Biggs    (918) 286-5000      
Principal Investigator: Daniel Nader, D.O.         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristina Maletteri       krisma@pennmedicine.upenn.edu   
Principal Investigator: Anil Vachani, M.D.         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard J. Criner, MD    215-707-2000      
Contact: JiJi Thomas    (215) 707-2000      
Principal Investigator: Gerard J. Criner, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Kopas         
Contact: Raquel R Bunge    713-441-3912      
Principal Investigator: Lisa Kopas, M.D.         
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Shiyue Li, M.D.         
Principal Investigator: Shiyue Li, M.D.         
China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China
Contact: Jiayuan Sun, M.D.         
Principal Investigator: Jiayuan Sun, M.D.         
Germany
ThoraxKlinik Recruiting
Heidelberg, Germany
Contact: Felix Herth, M.D.         
Principal Investigator: Felix Herth, M.D.         
Hong Kong
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, Hong Kong
Contact: Bing Lam, M.D.         
Principal Investigator: Bing Lam, M.D.         
Sponsors and Collaborators
Broncus Medical Inc

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Responsible Party: Broncus Medical Inc
ClinicalTrials.gov Identifier: NCT02867371     History of Changes
Other Study ID Numbers: Protocol 44
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018