DiagnosisNCT07326072
The Study of ENB With Ultra-thin Cryobiopsy in the Diagnosis of Peripheral Pulmonary Nodules
A study testing Cryobiopsy and Forceps biopsy in people with Diagnosis, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diagnosis
- What is being tested?
- Cryobiopsy and Forceps biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Conditions
- Diagnosis
- Being tested
- Cryobiopsy, Forceps biopsy
- Keywords
- Diagnosis, Peripheral pulmonary lesions, Cryobiopsy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryobiopsyProcedure or surgery
Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.
Forceps biopsyProcedure or surgery
Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy group | Experimental | Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy Receives: Procedure: Cryobiopsy |
| Forceps biopsy group | Active comparator | Electromagnetic Navigation Bronchoscopic with Forceps Biopsy Receives: Procedure: Forceps biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions
Measured: follow-up for 12 months
Secondary outcomes (1)
Adverse events
Adverse events related to the research
Measured: follow-up for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start5 Sep 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Wang, Doctor, Study chair, Beijing Chaoyang Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326072
- Sponsor's protocol ID
- MR-11-25-060861
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share clinical date.
Publications
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.
PubMed 39293856Tang 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.
PubMed 37914556Bondue 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.
PubMed 33902504Matsumoto 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.
PubMed 34022184Nakai 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.
PubMed 35000601Nakai 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.
PubMed 37379810Kim 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.
PubMed 38379178Kim 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.
PubMed 37380091
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of Electromagnetic Navigation Bronchoscopic With Ultra-thin Cryobiopsy and Forceps Biopsy in the Diagnosis of Peripheral Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT07326072
- Acronym / sponsor ID
- MR-11-25-060861
- Conditions
- Diagnosis
- Keywords
- Diagnosis, Peripheral pulmonary lesions, Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy group | Experimental | Procedure: CryobiopsyElectromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy |
| Forceps biopsy group | Active comparator | Procedure: Forceps biopsyElectromagnetic Navigation Bronchoscopic with Forceps Biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryobiopsyCryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each. | Procedure or surgery | Cryobiopsy group |
| Forceps biopsyForceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping. | Procedure or surgery | Forceps biopsy group |
Primary outcome
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
1 secondary outcome
Adverse events
Time frame: follow-up for one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 39293856Balasubramanian 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.
- Results publication: PubMed 37914556Tang 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.
- Results publication: PubMed 33902504Bondue 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.
- Results publication: PubMed 34022184Matsumoto 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.
- Results publication: PubMed 35000601Nakai 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.
- Results publication: PubMed 37379810Nakai 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.
- Results publication: PubMed 38379178Kim 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.
- Results publication: PubMed 37380091Kim 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.
- Individual participant dataSharing planned: Yes. We will share clinical date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Wang, Doctor study chair
Beijing Chaoyang Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryobiopsy and Forceps biopsy in people with Diagnosis, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: follow-up for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326072, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.