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

NCT04331587 | Completed FDA Device

• 1 other identifier: 202003071
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of related adverse events

  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

  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

  From start of procedure through end of procedure (day 1)

Study Arms (1)

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

Interventions

BF-P190 4 mm thin bronchoscope DEVICE

* EVIS EXERA III Bronchofiberviedoscopes * Olympus

Bronchoscopy

BF-MP190F 3 mm ultrathin bronchoscope DEVICE

* EVIS EXERA III Bronchofiberviedoscopes * Olympus

Bronchoscopy

Radial ultrasound probe (UM S20-17S) DEVICE

-Olympus

Bronchoscopy

PeriView FLEX 21G Single Use Aspiration Needle DEVICE

* NA-403D-2021 * Gyrus ACMI, Inc.

Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being seen at Washington University School of Medicine.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Olympus: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Alexander Chen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: April 20, 2020
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)