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

Peripheral Pulmonary Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331587
• Other study ID #: 202003071
• Status: Recruiting
• Start date: April 20, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Alexander Chen, M.D.
• Phone: 314-454-8764
• Email: chenac[@]wusl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Device:
• BF-P190 4 mm thin bronchoscope
EVIS EXERA III Bronchofiberviedoscopes Olympus
• BF-MP190F 3 mm ultrathin bronchoscope
EVIS EXERA III Bronchofiberviedoscopes Olympus
• Radial ultrasound probe (UM S20-17S)
-Olympus
• PeriView FLEX 21G Single Use Aspiration Needle
NA-403D-2021 Gyrus ACMI, Inc.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	Size of target lesions measured at the greatest diameter in centimeters		From start of procedure through end of procedure (day 1)
Secondary	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)
Secondary	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)
Secondary	Types of deficiencies associated with medical device		From start of procedure through end of procedure (day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine