Pulmonary FibrosisNCT06251687
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
A study testing Transbronchial Cryobiopsy，TBLC and Transbronchial Lung Biopsy，TBLB in people with Pulmonary Fibrosis and Transbronchial Cryobiopsy, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis, Transbronchial Cryobiopsy
- What is being tested?
- Transbronchial Cryobiopsy，TBLC and Transbronchial Lung Biopsy，TBLB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.
Who cannot join
- Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, +86 18801336854, isdeng1017@163.com
About this study
Official title: Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study
The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.
- Conditions
- Pulmonary Fibrosis, Transbronchial Cryobiopsy
- Being tested
- Transbronchial Cryobiopsy，TBLC, Transbronchial Lung Biopsy，TBLB
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial Cryobiopsy，TBLCProcedure or surgery
Transbronchial lung cryobiopsy (TBLC) is a novel technique that has proved its diagnostic value in various diffuse parenchymal lung diseases
Transbronchial Lung Biopsy，TBLBProcedure or surgery
Transbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial Cryobiopsy (TBLC) | Experimental | Transbronchial lung cryobiopsy (TBLC) has been increasingly utilised to diagnose diffuse parenchymal lung diseases Receives: Procedure: Transbronchial Cryobiopsy，TBLC |
| Transbronchial Lung Biopsy (TBLB) | Active comparator | Transbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease Receives: Procedure: Transbronchial Lung Biopsy，TBLB |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic performance of transbronchial cryobiopsy（TBLC）
the sensitivity and specificity of transbronchial cryobiopsy（TBLC）in suspected progressive pulmonary fibrosis
Measured: 1 month after transbronchial cryobiopsy
Secondary outcomes (1)
the safety of transbronchial cryobiopsy（TBLC)
The occurence of short-term procedure-related complications, including Bleeding, pneumothorax, death, etc
Measured: 7 days and 1 month after transbronchial cryobiopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251687
- Sponsor's protocol ID
- ZRJY2021-BJ08-03-01-02
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06251687
- Acronym / sponsor ID
- ZRJY2021-BJ08-03-01-02
- Conditions
- Pulmonary Fibrosis, Transbronchial Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2024 (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.
The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transbronchial Cryobiopsy (TBLC) | Experimental | Procedure: Transbronchial Cryobiopsy，TBLCTransbronchial lung cryobiopsy (TBLC) has been increasingly utilised to diagnose diffuse parenchymal lung diseases |
| Transbronchial Lung Biopsy (TBLB) | Active comparator | Procedure: Transbronchial Lung Biopsy，TBLBTransbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.
Key exclusion criteria (1 listed)
- Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
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 |
|---|---|---|
| Transbronchial Cryobiopsy，TBLCTransbronchial lung cryobiopsy (TBLC) is a novel technique that has proved its diagnostic value in various diffuse parenchymal lung diseases | Procedure or surgery | Transbronchial Cryobiopsy (TBLC) |
| Transbronchial Lung Biopsy，TBLBTransbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease | Procedure or surgery | Transbronchial Lung Biopsy (TBLB) |
Primary outcome
the diagnostic performance of transbronchial cryobiopsy（TBLC）
Time frame: 1 month after transbronchial cryobiopsy
the sensitivity and specificity of transbronchial cryobiopsy（TBLC）in suspected progressive pulmonary fibrosis
1 secondary outcome
the safety of transbronchial cryobiopsy（TBLC)
Time frame: 7 days and 1 month after transbronchial cryobiopsy
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 10 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial Cryobiopsy，TBLC and Transbronchial Lung Biopsy，TBLB in people with Pulmonary Fibrosis and Transbronchial Cryobiopsy, run by China-Japan Friendship 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic performance of transbronchial cryobiopsy（TBLC） (time frame: 1 month after transbronchial cryobiopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.