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

The Washington University

Status: Completed

Conditions: Peripheral Pulmonary Nodules

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04331587

202003071

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

Bronchoscopy

Description:

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.

Treatment:

Device: PeriView FLEX 21G Single Use Aspiration Needle

Device: BF-MP190F 3 mm ultrathin bronchoscope

Device: Radial ultrasound probe (UM S20-17S)

Device: BF-P190 4 mm thin bronchoscope