Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

NCT05512533 | Completed DMC

• 1 other identifier: SHCHE202208
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)

Conditions

Peripheral Pulmonary Lesions

Keywords

EBUS-TBNA; diagnostic yield; peripheral pulmonary lesions (PPLs)

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of BF-UC290F for PPLs

  Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.

  Up to 6 months

Secondary Outcomes (5)

• EBUS scope operation time

  Immediately after each operation

• The total time of lesion access

  Immediately after Each Operation

• Factors affecting the diagnosis rate

  Up to 6 months

• The bronchus level of lesions, and the bronchus level reached with the EBUS scope

  During the procedure

• Specimen adequacy

  Up to 6 months

Other Outcomes (1)

• Safety Outcome: Complication rate

  1 month

Study Arms (1)

BF-UC290F for diagnosing PPLs

EXPERIMENTAL

Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA.

Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus)

Interventions

Linear Ultrasound Bronchoscope BF-UC290F (Olympus) DEVICE

A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus).

BF-UC290F for diagnosing PPLs

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years old.
• Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are close to 5mm in diameter, thus BF-UC290F is able to arrival/access).
• Patients without contraindications of bronchoscopy.
• Patients have good medical adherence and signed informed consent.

You may not qualify if:

• Peripheral pulmonary lesion is pure ground-glass opacity.
• Visible lumen lesions during bronchoscopy
• The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
• The investigators believe that patient has other conditions that are not suitable for the study.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (2)

• Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005.

  PMID: 33447457 BACKGROUND

• Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2.

  PMID: 30610852 BACKGROUND

Study Officials

• Jiayuan Sun, MD., PhD.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endoscopy

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: September 2, 2022
• Primary Completion: February 12, 2023
• Study Completion: July 12, 2023
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)