Clinical Trial

Novel Thin Bronchoscope Versus Ultrathin Bronchoscope for the Diagnosis of Peripheral Pulmonary Nodules

Not Yet Recruiting
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Record status
This record was last updated August 22, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a prospective, randomised, non-inferior, multicenter study in consecutive patients with solid or sub-solid PPLs 8 to 30 mm in diameter.The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures will be performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps will be used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps will be used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield.
Trial Details
NCT Number NCT07135297
Lead Sponsor Shanghai Chest Hospital
Conditions Lung Cancer (Diagnosis)
Enrollment 465 participants
Start Date 2025-09-01
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-22