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

Recruiting

• Conditions: Peripheral Pulmonary Nodules
• Interventions: 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

• Registration Number: NCT04331587
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-04-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchoscopy	BF-MP190F 3 mm ultrathin bronchoscope	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.
Bronchoscopy	Radial ultrasound probe (UM S20-17S)	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.
Bronchoscopy	BF-P190 4 mm thin bronchoscope	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.
Bronchoscopy	PeriView FLEX 21G Single Use Aspiration Needle	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Types of deficiencies associated with medical device	From start of procedure through end of procedure (day 1)
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
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
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).
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)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States