Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions

Study Overview
=================
Brief Summary
-----------------
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.

Official Title
-----------------
Evaluation of Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions

Conditions
-----------------
Peripheral Pulmonary Nodules

Intervention / Treatment
-----------------
* Device: BF-P190 4 mm thin bronchoscope
* Device: BF-MP190F 3 mm ultrathin bronchoscope
* Device: Radial ultrasound probe (UM S20-17S)
* Device: PeriView FLEX 21G Single Use Aspiration Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 and older Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes Exclusion Criteria: Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure Patients unwilling or unable to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchoscopy<br>The bronchoscopy procedure and use of both the thin and ultrathin bronchoscopes are considered standard of care and will be performed under moderate sedation in an outpatient bronchoscopy suite as part of each patient's clinical care. | Device: BF-P190 4 mm thin bronchoscope<br>* EVIS EXERA III Bronchofiberviedoscopes Olympus<br>Device: BF-MP190F 3 mm ultrathin bronchoscope<br>* EVIS EXERA III Bronchofiberviedoscopes Olympus<br>Device: Radial ultrasound probe (UM S20-17S)<br>* -Olympus<br>Device: PeriView FLEX 21G Single Use Aspiration Needle<br>* NA-403D-2021 Gyrus ACMI, Inc.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules | -To determine overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules utilizing using a standard of care combined approach of 4mm thin and 3mm ultrathin bronchoscopes with TBNA and radial EBUS and compare it to a historical baseline diagnostic yield of 60% established at Washington University School of Medicine (WUSM) when using TBNA and radial EBUS and a 4mm thin bronchoscope. | Receipt of cytology/histopathology results (approximately 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of related adverse events | -Adverse events related to the bronchoscopy procedure and/or devices used during the procedure (bronchoscope, radial EBUS, PeriView Flex needle). | Up to 4 days following procedure | 
| Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure |  | From start of procedure through end of procedure (day 1) | 
| Size of target lesions measured at the greatest diameter in centimeters |  | From start of procedure through end of procedure (day 1) | 
| Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions | -Will be compared with historical controlled data of cases in which peripheral bronchoscopy was performed for peripheral lesions using radial probe EBUS and a 4mm bronchoscope in which eccentric ultrasound views were obtained | Receipt of cytology/histopathology results (approximately 7 days) | 
| Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope | -The ability to convert will be based on the ultrasound image that is obtained using the 3mm bronchoscope (it will either be eccentric or concentric) compared to the eccentric ultrasound image obtained with the 4mm bronchoscope | From start of procedure through end of procedure (day 1) | 
| Types of deficiencies associated with medical device |  | From start of procedure through end of procedure (day 1) |