Efficacy and safety clinical trial in SKD-001
- Conditions
- Pts with abnormal chest shadows that are difficult to biopsy using nomal bronchoscopic procedure
- Registration Number
- JPRN-jRCT2052220174
- Lead Sponsor
- Miyake Kotaro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic rate of specimens collected achieving the prescribed proceduer
- Secondary Outcome Measures
Name Time Method - Number of branches progressed from branches that bronchoscope could not pass-through<br>- Diagnostic coincidence rate of specimens collected achieving the prescribed procedure