Evaluation of the Archimedes™ System for Transparenchymal Nodule Access
NCT ID: NCT02460120
Last Updated: 2017-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2015-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Navigation and tissue sampling
Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System
Archimedes System
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Interventions
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Archimedes System
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Eligibility Criteria
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Inclusion Criteria
2. Highly suspicious SPN, 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. Signs study-related informed consent document
Exclusion Criteria
* Untreatable life-threatening arrhythmias
* Inability to adequately oxygenate the patient during the procedure
* Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
* Recent myocardial infarction
* Previously diagnosed high-grade tracheal obstruction
* 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 SPN
9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
* ASA class \> 3
* \> stage 3 heart failure
* severe cachexia
* 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. Pregnancy
21 Years
75 Years
ALL
No
Sponsors
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Broncus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Nader, D.O.
Role: PRINCIPAL_INVESTIGATOR
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Locations
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Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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Protocol 43
Identifier Type: -
Identifier Source: org_study_id
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