NCT07326072

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2025Jul 2027

Study Start

First participant enrolled

September 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

January 13, 2026

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

December 24, 2025

Last Update Submit

January 11, 2026

Conditions

Diagnosis

Keywords

DiagnosisPeripheral pulmonary lesionsCryobiopsy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

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

    follow-up for 12 months

Secondary Outcomes (1)

  • Adverse events

    follow-up for one month

Study Arms (2)

Cryobiopsy group

EXPERIMENTAL

Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy

Procedure: Cryobiopsy

Forceps biopsy group

ACTIVE COMPARATOR

Electromagnetic Navigation Bronchoscopic with Forceps Biopsy

Procedure: Forceps biopsy

Interventions

CryobiopsyPROCEDURE

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

Cryobiopsy group
Forceps biopsyPROCEDURE

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

Forceps biopsy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (8)

  • Balasubramanian P, Abia-Trujillo D, Barrios-Ruiz A, Garza-Salas A, Koratala A, Chandra NC, Yu Lee-Mateus A, Labarca G, Fernandez-Bussy S. Diagnostic yield and safety of diagnostic techniques for pulmonary lesions: systematic review, meta-analysis and network meta-analysis. Eur Respir Rev. 2024 Sep 18;33(173):240046. doi: 10.1183/16000617.0046-2024. Print 2024 Jul.

    PMID: 39293856RESULT

  • Tang Y, Tian S, Chen H, Li X, Pu X, Zhang X, Zheng Y, Li Y, Huang H, Bai C. Transbronchial lung cryobiopsy for peripheral pulmonary lesions. A narrative review. Pulmonology. 2024 Sep-Oct;30(5):475-484. doi: 10.1016/j.pulmoe.2023.08.010. Epub 2023 Oct 31.

    PMID: 37914556RESULT

  • Bondue B, Schlossmacher P, Allou N, Gazaille V, Taton O, Gevenois PA, Vandergheynst F, Remmelink M, Leduc D. Trans-bronchial lung cryobiopsy in patients at high-risk of complications. BMC Pulm Med. 2021 Apr 26;21(1):135. doi: 10.1186/s12890-021-01503-9.

    PMID: 33902504RESULT

  • Matsumoto Y, Nakai T, Tanaka M, Imabayashi T, Tsuchida T, Ohe Y. Diagnostic Outcomes and Safety of Cryobiopsy Added to Conventional Sampling Methods: An Observational Study. Chest. 2021 Nov;160(5):1890-1901. doi: 10.1016/j.chest.2021.05.015. Epub 2021 May 19.

    PMID: 34022184RESULT

  • Nakai T, Watanabe T, Kaimi Y, Ogawa K, Matsumoto Y, Sawa K, Okamoto A, Sato K, Asai K, Matsumoto Y, Ohsawa M, Kawaguchi T. Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions. BMC Pulm Med. 2022 Jan 10;22(1):20. doi: 10.1186/s12890-021-01817-8.

    PMID: 35000601RESULT

  • Nakai T, Watanabe T, Kaimi Y, Shiomi K, Ando K, Miyamoto A, Ogawa K, Matsumoto Y, Sawa K, Sato K, Asai K, Matsumoto Y, Mikami Y, Ohsawa M, Kawaguchi T. Diagnostic Utility and Safety of Non-Intubated Cryobiopsy Technique Using a Novel Ultrathin Cryoprobe in Addition to Conventional Biopsy Techniques for Peripheral Pulmonary Lesions. Respiration. 2023;102(7):503-514. doi: 10.1159/000531010. Epub 2023 Jun 28.

    PMID: 37379810RESULT

  • Kim MH, Kim SH, Lee G, Mok J, Lee MK, Song JS, Eom JS. Next-generation sequencing using tissue specimen collected with a 1.1 mm-diameter cryoprobe in patients with lung cancer. Respirology. 2024 Apr;29(4):333-339. doi: 10.1111/resp.14680. Epub 2024 Feb 20.

    PMID: 38379178RESULT

  • Kim SH, Mok J, Kim S, Yoo WH, Jo EJ, Kim MH, Lee K, Kim KU, Park HK, Lee MK, Eom JS. Clinical outcomes of transbronchial cryobiopsy using a 1.1-mm diameter cryoprobe for peripheral lung lesions - A prospective pilot study. Respir Med. 2023 Oct;217:107338. doi: 10.1016/j.rmed.2023.107338. Epub 2023 Jun 26.

    PMID: 37380091RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Feng Wang, Doctor

    Beijing Chaoyang Hospital, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The subjects were randomly (1:1) divided into groups. Cryobiopsy was assigned to the experimental group, while biopsy using a biopsy forceps was assigned to the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

September 5, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

January 13, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

We will share clinical date.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available for sharing for 2 years after formal publication of the study.
Access Criteria
Researchers working on cryobiopsy and electromagnetic navigation bronchoscopy.

Locations

CN(1)