Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
NCT Number: NCT05512533
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200030, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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
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.
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.
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
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
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
Shanghai Chest Hospital
Other
Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
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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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