Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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-Navigation and tissue sampling

Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System

Group Type EXPERIMENTAL

Archimedes System

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No