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OpenTrials
Completed

NCT Number: NCT05512533

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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).

Primary outcomes

  1. Diagnostic yield of BF-UC290F for PPLs

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. EBUS scope operation time

    Time frame: Immediately after each operation

    It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope

  2. The total time of lesion access

    Time frame: Immediately after Each Operation

    It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.

  3. Factors affecting the diagnosis rate

    Time frame: Up to 6 months

    Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.

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

    Time frame: During the procedure

    Level: Main bronchus is level 0, lobar bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3

  5. Specimen adequacy

    Time frame: Up to 6 months

    The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection

Other outcomes

  1. Safety Outcome: Complication rate

    Time frame: 1 month

    The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
Registry last updated
Jun 5, 2025

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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