An interventional study of CassiII rotational core biopsy and Automated biopsy in Peripheral Pulmonary Lesions (PPLs) and Pulmonary Nodules, sponsored by Beijing Chao Yang Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Diagnostic
This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique（CassiII rotational core biopsy） versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.
If a chest CT scan reveals pulmonary nodules with an unknown nature, a biopsy is required for definitive diagnosis; if the chest CT shows multiple pulmonary nodules, one of these nodules should be selected as the target lesion;
Exclusion Criteria:
Severe cardiopulmonary dysfunction;
Irreversible coagulation disorders;
Suspected vascular lesions or arteriovenous malformations (assessed by contrast-enhanced CT), or presence of bronchial artery penetration at the planned biopsy site, or suspected pulmonary metastasis from renal cell carcinoma, indicating a high risk of hemorrhage;
PET-CT findings indicate a malignant pulmonary nodule; surgical evaluation may prioritize surgical intervention for the patient;
Pregnant or lactating women; ⑥ Patients with psychiatric disorders or those unable to cooperate during the puncture procedure; ⑦ Presence of anesthesia contraindications; allergy to anesthetic agents; or a history of multiple severe allergies or hereditary allergies;
Under CT guidance, a percutaneous puncture is performed using a coaxial needle; upon reaching the target lesion, the CassiII rotational core biopsy needle is inserted along the coaxial needle for biopsy. At the same lesion site, ≥1 biopsy is performed; depending on sample adequacy, the maximum number of biopsies shall not exceed 3, with at least 1 tissue specimen obtained from each biopsy. Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
Procedure: CassiII rotational core biopsy
Under CT guidance, a coaxial needle is percutaneously inserted; upon reaching the target lesion, an automated biopsy needle is advanced along the coaxial needle and activated. Biopsy is performed at least once at the same lesion site; depending on sample adequacy, the procedure may be repeated up to a maximum of 3 times, with at least one tissue specimen obtained from each attempt. Subsequently, the automated biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
Procedure: Automated biopsy
CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Diagnostic yield of the two biopsy methods
Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%
Time frame: From enrollment to the end of procedure at 2 years
Specimen size
biopsy tissue size (long diameter, millimeter)
Time frame: From enrollment to the end of procedure at 2 years
Consistency analysis between AI-ROSE results and pathological results
The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE
Time frame: From enrollment to the end of procedure at 2 years
Safety indicators
Complications: Incidence (including pneumothorax, hemorrhage, respiratory failure, infection, and severe complications requiring endotracheal intubation and mechanical ventilation to be transferred to the Intensive Care Unit), severity levels, and corresponding management measures.
Time frame: From enrollment to the end of procedure at 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Chao Yang Hospital