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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases
Study Purpose
The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse
parenchymal lung diseases are investigated in this multicenter, prospective and real world
study.
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.
Observational
Eligible Ages
N/A and Over
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.
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.
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.
Shiyue Li
Principal Investigator Affiliation
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
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.
Diffuse Parenchymal Lung Diseases
Arms & Interventions
Arms
: Cryobiopsy
Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
Interventions
Procedure: - Transbronchial cryobiopsy
Transbronchial cryobiopsy procedure
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.