臨床研究等提出・公開システム

Effectiveness and Safety Study on SKD-001

Effectiveness and Safety Study on SKD-001

Miyake Kotaro

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

kotaromiyake@imed3.med.osaka-u.ac.jp

Terada Shimpei

KANEKA CORPORATION

2-3-18, Nakanoshima, Kita-ku Osaka

+81-50-3181-4126

Shimpei.Terada@kaneka.co.jp

Complete

Feb. 22, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

(1) Patients who have an abnormal chest shadow with a positive bronchus-sign
(2) Patients with an abnormal chest shadow less than 2 cm
(3) Patients with peripheral pulmonary lesions that cannot be visualized with a bronchoscopy
(4) Patients who are 20 years of age or older at the time of consent
(5) Patients whose written consent to voluntarily participate in the clinical trial can be obtained from themselves

(1) Patients who are unable to undergo a bronchoscopy
(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

Both

Referring to other1 because of character limit

Expand SKD-001 at the branch where the bronchoscope can not pass-through.

Diagnostic rate of specimens collected by performing the specified procedure

- The number of advanced bifurcations beyond the bifurcation where the bronchoscope cannot pass through
- Diagnostic yield of specimens collected by performing the specified procedure

+81-6-6210-8290

No

none