Efficacy and safety clinical trial in SKD-001

JRCT ID: jRCT2052220174

Registered date:23/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pts with abnormal chest shadows that are difficult to biopsy using nomal bronchoscopic procedure
• Date of first enrollment: 22/02/2023
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Expand SKD-001 at the branch where the bronchoscope can not pass-through.

Outcome(s)

• Primary Outcome: Diagnostic 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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Miyake Kotaro