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

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

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.

Study Overview

• Status: Recruiting
• 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

• Study Type: Observational
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Chen, M.D.; Phone Number: 314-454-8764; Email: chenac@wusl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Alexander Chen, M.D.; Phone Number: 314-454-8764; Email: chenac@wustl.edu
      • Principal Investigator: Alexander Chen, M.D.
      • Sub-Investigator: Praveen Chenna, M.D.
      • Sub-Investigator: Nathaniel Moulton, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being seen at Washington University School of Medicine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bronchoscopy; 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; EVIS EXERA III Bronchofiberviedoscopes; Olympus; Device: BF-MP190F 3 mm ultrathin bronchoscope; EVIS EXERA III Bronchofiberviedoscopes; Olympus; Device: Radial ultrasound probe (UM S20-17S); -Olympus; Device: PeriView FLEX 21G Single Use Aspiration Needle; NA-403D-2021; Gyrus ACMI, Inc.

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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Olympus
• Investigators: Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 202003071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No