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Clinical Trials in China / NCT07326072
Enrolling by invitation Not applicable

The Study of ENB With Ultra-thin Cryobiopsy in the Diagnosis of Peripheral Pulmonary Nodules

NCT07326072 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Chao Yang Hospital
Phase
Not applicable
Started
2025-09-05
Last updated
2026-01-13

Condition(s) studied

Diagnosis

Investigational drug(s) / intervention(s)

CryobiopsyForceps biopsy

Cryobiopsy: Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.

Forceps biopsy: Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.

Study summary

To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: 1. age 18 to 90 years; 2. pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy; 3. chest CT showed that the nodule was located in the segmental bronchus and below, and the maximum diameter of the nodule was 8 mm to 30 mm.It was not accessible by conventional bronchoscopy; 4. if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion. Exclusion Criteria: 1. contraindications to the bronchoscopy procedure; 2. high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma; 3. electromagnetic source implanted in the body; 4. contraindications to anesthesia; 5. pregnant woman; 6. participated in other studies within three months and did not withdraw or finish, affect the observation of this study; 7. inability or unwillingness to provide informed consent or comply with the follow-up schedule.

Primary outcome measure(s)

  • Diagnostic yield — follow-up for 12 months
    The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions

Trial sites (1)

FacilityCityRegionStatus
Beijing Chaoyang Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07326072 on ClinicalTrials.gov ↗ ← All trials in China