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Enrolling by Invitation

NCT Number: NCT07326072

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

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

Enrolling by Invitation

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

About this study

This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 to 90 years;
  • pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy;
  • 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;
  • if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.

Exclusion criteria

  • contraindications to the bronchoscopy procedure;
  • high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma;
  • electromagnetic source implanted in the body;
  • contraindications to anesthesia;
  • pregnant woman;
  • participated in other studies within three months and did not withdraw or finish, affect the observation of this study;
  • inability or unwillingness to provide informed consent or comply with the follow-up schedule.

Treatment and study plan

Cryobiopsy

Procedure

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

Forceps biopsy

Procedure

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

Primary outcomes

  1. Diagnostic yield

    Time frame: follow-up for 12 months

    The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions

Secondary outcomes

  1. Adverse events

    Time frame: follow-up for one month

    Adverse events related to the research

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

The Comparative Study of Electromagnetic Navigation Bronchoscopic With Ultra-thin Cryobiopsy and Forceps Biopsy in the Diagnosis of Peripheral Pulmonary Nodules

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 13, 2026

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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