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

NCT ID: NCT04331587

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2024-08-22

Brief Summary

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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

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Conditions

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Peripheral Pulmonary Nodules

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

BF-P190 4 mm thin bronchoscope

Intervention Type DEVICE

* EVIS EXERA III Bronchofiberviedoscopes
* Olympus

BF-MP190F 3 mm ultrathin bronchoscope

Intervention Type DEVICE

* EVIS EXERA III Bronchofiberviedoscopes
* Olympus

Radial ultrasound probe (UM S20-17S)

Intervention Type DEVICE

-Olympus

PeriView FLEX 21G Single Use Aspiration Needle

Intervention Type DEVICE

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

Interventions

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BF-P190 4 mm thin bronchoscope

* EVIS EXERA III Bronchofiberviedoscopes
* Olympus

Intervention Type DEVICE

BF-MP190F 3 mm ultrathin bronchoscope

* EVIS EXERA III Bronchofiberviedoscopes
* Olympus

Intervention Type DEVICE

Radial ultrasound probe (UM S20-17S)

-Olympus

Intervention Type DEVICE

PeriView FLEX 21G Single Use Aspiration Needle

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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202003071

Identifier Type: -

Identifier Source: org_study_id

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