Clinical trial NCT02867371: Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Official title: Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Broncus Medical Inc
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 166
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Proportion of biopsies yielding tissue sufficient for diagnosis
timeFrame: Up to 1 year
Secondary outcomes:
measure: Procedure planning time
timeFrame: Up to 1 year
measure: Nodule access time
timeFrame: Up to 1 year
measure: Fluoroscopy time
timeFrame: Up to 1 year
measure: Patient registration time
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America at Southwestern Regional Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Heidelberg
country: Germany
facility: ThoraxKlinik
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
Study officials:
References: