Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.

Official Title
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Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Navigational Bronchoscopy
* Procedure: Standard Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy. Exclusion Criteria: Pulmonary nodules less than 1.0 cm patients must be able to tolerate general anesthesia patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal patients unable to tolerate bronchoscopy pregnant patients or patients who believe they are pregnant patients with implantable devices susceptible to Radio Frequency (RF) fields severely obese patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Navigational Bronch/Standard Bronch<br>Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed. | Procedure: Navigational Bronchoscopy<br> <br> * Other names: Veran Navigational System;Procedure: Standard Bronchoscopy<br> <br> * Other names: Standard Bronchoscope;|
| Active Comparator: Standard Bronch/Navigational Bronch<br>Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed. | Procedure: Navigational Bronchoscopy<br> <br> * Other names: Veran Navigational System;Procedure: Standard Bronchoscopy<br> <br> * Other names: Standard Bronchoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy | This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules |  | up to 1 year | 
| Total virtual bronchoscopy time | Information will be gathered at time of procedure | Day 1 | 
| Total procedure time | This information will be gathered at the time of procedure | Day 1 |