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Completed

NCT Number: NCT04331587

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.

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Key information

Conditions

Peripheral Pulmonary Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BF-P190 4 mm thin bronchoscope

Device
  • EVIS EXERA III Bronchofiberviedoscopes
  • Olympus

BF-MP190F 3 mm ultrathin bronchoscope

Device
  • EVIS EXERA III Bronchofiberviedoscopes
  • Olympus

Radial ultrasound probe (UM S20-17S)

Device

-Olympus

PeriView FLEX 21G Single Use Aspiration Needle

Device
  • NA-403D-2021
  • Gyrus ACMI, Inc.

Primary outcomes

  1. Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules

    Time frame: 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 outcomes

  1. Incidence of related adverse events

    Time frame: 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).

  2. Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure

    Time frame: From start of procedure through end of procedure (day 1)

  3. Size of target lesions measured at the greatest diameter in centimeters

    Time frame: From start of procedure through end of procedure (day 1)

  4. Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions

    Time frame: 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

  5. Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope

    Time frame: 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

  6. Types of deficiencies associated with medical device

    Time frame: From start of procedure through end of procedure (day 1)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Olympus

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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