NIPH Clinical Trials Search

JRCT ID: jRCT2052220174

Registered date:23/02/2023

Efficacy and safety clinical trial in SKD-001

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPts with abnormal chest shadows that are difficult to biopsy using nomal bronchoscopic procedure
Date of first enrollment22/02/2023
Target sample size22
Countries of recruitment
Study typeInterventional
Intervention(s)Expand SKD-001 at the branch where the bronchoscope can not pass-through.


Primary OutcomeDiagnostic rate of specimens collected achieving the prescribed proceduer
Secondary Outcome- Number of branches progressed from branches that bronchoscope could not pass-through - Diagnostic coincidence rate of specimens collected achieving the prescribed procedure

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria(1) Patients with an abnormal chest shadow positive for CT bronchus-sign (2) Patients with an abnormal chest shadow less than 2 cm (3) Patients with peripheral lesions in the lung field where an abnormal chest shadow cannot be observed by bronchoscopy (4) Patients who are 20 years of age or older at the time of consent (5) Patients who are able to obtain free and voluntary written consent for participation in the clinical trial
Exclude criteria(1) Patients for whom bronchoscopy cannot be performed (2) Patients undergoing procedures for multiple target lesions (3) Patients with hypersensitivity to anesthetics or other drugs used in bronchoscopy (excluding patients for whom another drug can be used) (4) Patients with serious circulatory, renal, or hepatic dysfunction (5) Patients with respiratory insufficiency or bleeding, coughing, etc. that make it difficult to perform or continue bronchoscopy and prevent proper evaluation of this clinical trial (6) Patients with hypersensitivity to ethylene oxide (7) Patients who are pregnant, lactating, or of childbearing potential (8) Patients who have participated in other clinical trials within 3 months of obtaining consent (9) Other patients deemed inappropriate by the investigator or Sub Inestigators

Related Information


Public contact
Name Shimpei Terada
Address 2-3-18, Nakanoshima, Kita-ku Osaka Osaka Japan 530-8288
Telephone +81-50-3181-4126
Scientific contact
Name Kotaro Miyake
Address 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-5111
Affiliation Osaka University Hospital