Transbronchial CryobiopsyNCT03927235
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases
A study testing Transbronchial Cryobiopsy in people with Transbronchial Cryobiopsy and Freezing Time, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield
- What is being tested?
- Transbronchial Cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2019to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.
Who cannot join
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Shiyue Li, professor, 13902233925, lishiyue@188.com
Yao Yao, Dr, 18826401822, yaoyaogy2016@163.com
About this study
Official title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
Read the detailed description
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.
- Conditions
- Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield, Safety
- Being tested
- Transbronchial Cryobiopsy
- Keywords
- Transbronchial Cryobiopsy, freezing time, Diagnostic Yield, Safety, Diffuse Parenchymal Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial CryobiopsyProcedure or surgery
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
| Study group | Role | What they receive |
|---|---|---|
| the freezing time of 3s | Sham comparator | Transbronchial cryobiopsy in the freezing time of 3s Receives: Procedure: Transbronchial Cryobiopsy |
| the freezing time of 4s | Experimental | Transbronchial cryobiopsy in the freezing time of 4s Receives: Procedure: Transbronchial Cryobiopsy |
| the freezing time of 5s | Experimental | Transbronchial cryobiopsy in the freezing time of 5s Receives: Procedure: Transbronchial Cryobiopsy |
| the freezing time of 6s | Experimental | Transbronchial cryobiopsy in the freezing time of 6s Receives: Procedure: Transbronchial Cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
Measured: two weeks
Secondary outcomes (1)
Complication rate
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start16 May 2019
- Primary completion15 May 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transbronchial CryobiopsyStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927235
- Sponsor's protocol ID
- 2018-3-30
- Status last verified
- May 2019
- First submitted
- 23 Apr 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03927235
- Acronym / sponsor ID
- 2018-3-30
- Conditions
- Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield, Safety
- Keywords
- Transbronchial Cryobiopsy, freezing time, Diagnostic Yield, Safety, Diffuse Parenchymal Lung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 25 Apr 2019 (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.
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
Detailed description
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| the freezing time of 3s | Sham comparator | Procedure: Transbronchial CryobiopsyTransbronchial cryobiopsy in the freezing time of 3s |
| the freezing time of 4s | Experimental | Procedure: Transbronchial CryobiopsyTransbronchial cryobiopsy in the freezing time of 4s |
| the freezing time of 5s | Experimental | Procedure: Transbronchial CryobiopsyTransbronchial cryobiopsy in the freezing time of 5s |
| the freezing time of 6s | Experimental | Procedure: Transbronchial CryobiopsyTransbronchial cryobiopsy in the freezing time of 6s |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.
Key exclusion criteria (3 listed)
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
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 CryobiopsyTransbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases | Procedure or surgery | the freezing time of 3s, the freezing time of 4s, the freezing time of 5s, the freezing time of 6s |
Primary outcome
Diagnotic yield
Time frame: two weeks
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
1 secondary outcome
Complication rate
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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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. This study is not recruiting at the moment.
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 in people with Transbronchial Cryobiopsy and Freezing Time, run by Guangzhou Institute of Respiratory Disease 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Chen, master (+8613751721744, xiaobo-win@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnotic yield (time frame: two weeks). 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 30 May 2019.