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

NCT ID: NCT05512533

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2023-07-12

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)

Detailed Description

This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.

Conditions

Peripheral Pulmonary Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BF-UC290F for diagnosing PPLs

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

Group Type: EXPERIMENTAL

Linear Ultrasound Bronchoscope BF-UC290F (Olympus)

Intervention Type: 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).

Interventions

Linear Ultrasound Bronchoscope BF-UC290F (Olympus)

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Director, Department of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Sun, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 33447457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30610852 (View on PubMed)

Other Identifiers

SHCHE202208

Identifier Type: -

Identifier Source: org_study_id