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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06275295
Other study ID # ZRJY2021-BJ08-03-01-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source China-Japan Friendship Hospital
Contact Gang Hou, Professor
Phone 1384005481
Email hougangcmu@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy(TBLC) in progressive pulmonary fibrosis.


Description:

The goal of this observational 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: • The diagnostic rate of MDD1 or MDD2 based on TBLC. • The rate of hemorrhage, pneumothorax, acute ILD exacerbation and mortality. Participants' medical records will be collected by us.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 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. Exclusion Criteria: Patients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The diagnostic rate of MDD2 based on TBLC the diagnostic rate of progressive pulmonary fibrosis after Transbronchial Cryobiopsy December,31,2024
Secondary The diagnostic rate of MDD1 the diagnostic rate of progressive pulmonary fibrosis before Transbronchial Cryobiopsy December,31,2024
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