Peripheral Pulmonary Nodules
Conditions
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.
Interventions
DEVICEBF-P190 4 mm thin bronchoscope
* EVIS EXERA III Bronchofiberviedoscopes * Olympus
DEVICEBF-MP190F 3 mm ultrathin bronchoscope
* EVIS EXERA III Bronchofiberviedoscopes * Olympus
DEVICERadial ultrasound probe (UM S20-17S)
-Olympus
DEVICEPeriView FLEX 21G Single Use Aspiration Needle
* NA-403D-2021 * Gyrus ACMI, Inc.
Sponsors
Olympus
Washington University School of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules | Receipt of cytology/histopathology results (approximately 7 days) | -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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Incidence of related adverse events | Up to 4 days following procedure | -Adverse events related to the bronchoscopy procedure and/or devices used during the procedure (bronchoscope, radial EBUS, PeriView Flex needle). |
| Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope | From start of procedure through end of procedure (day 1) | -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 |
| Types of deficiencies associated with medical device | From start of procedure through end of procedure (day 1) | — |
| Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions | Receipt of cytology/histopathology results (approximately 7 days) | -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 |
Countries
United States
Outcome results
None listed