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

January 11, 2026 updated by: Beijing Chao Yang Hospital

The Comparative Study of Electromagnetic Navigation Bronchoscopic With Ultra-thin Cryobiopsy and Forceps Biopsy 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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Beijing ChaoYang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryobiopsy group
Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy
Procedure: Cryobiopsy
Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.
Active Comparator: Forceps biopsy group
Electromagnetic Navigation Bronchoscopic with Forceps Biopsy
Procedure: Forceps biopsy
Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
follow-up for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: follow-up for one month
Adverse events related to the research
follow-up for one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Study Chair: Feng Wang, Doctor, Beijing Chaoyang Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-11-25-060861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share clinical date.

IPD Sharing Time Frame

Data will be available for sharing for 2 years after formal publication of the study.

IPD Sharing Access Criteria

Researchers working on cryobiopsy and electromagnetic navigation bronchoscopy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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