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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases

Study Purpose

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. 2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.

Exclusion Criteria:

1. The radiological data indicates non-DPLD. 2. The clinical examinations mentioned above are not completed. 3. The patient cannot endure or does not agree the procedure.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03927235
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangzhou Institute of Respiratory Disease
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield, Safety

Additional Details

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.

Arms & Interventions

Arms

Sham Comparator: the freezing time of 3s

Transbronchial cryobiopsy in the freezing time of 3s

Experimental: the freezing time of 4s

Transbronchial cryobiopsy in the freezing time of 4s

Experimental: the freezing time of 5s

Transbronchial cryobiopsy in the freezing time of 5s

Experimental: the freezing time of 6s

Transbronchial cryobiopsy in the freezing time of 6s

Interventions

Procedure: - Transbronchial Cryobiopsy

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Contact a Trial Team

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