Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 80
Updated:6/27/2018
Start Date:August 2016
End Date:February 2019
Contact:Daniel Nader, D.O.
Phone:918-286-5000

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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.


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
We found this trial at
7
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Anil Vachani, M.D.
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adnan Majid, M.D.
Phone: 617-632-8386
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Momen Wahidi, M.D.
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Guangzhou, Guangdong
Principal Investigator: Shiyue Li, M.D.
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Guangzhou,
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Lisa Kopas, M.D.
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Gerard J. Criner, MD
Phone: 215-707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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Tulsa, Oklahoma 74133
Principal Investigator: Daniel Nader, D.O.
Phone: 918-286-5000
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Tulsa, OK
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