UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Title of the study (Brief title)	Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Region	Japan

Condition
Condition	peripheral lung leisions doubting a malignancy
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the diagnostic yield and safety of ultrathin bronchoscope using Switch Oblique Method (SOM) in peripheral pulmonary lesions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	the accuracy of Switch Oblique Method as navigation system
Key secondary outcomes	the diagnostic yield and safety of ultrathin bronchoscope using Switch Oblique Method (SOM). complications of bronchoscopy. inspection time

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	bronchoscopy with switch oblique method
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Small peripheral pulmonary lesions of 10 mm or more and 20 mm or less deemed, but not determined, as lung cancer 2.Not visible by bronchoscopy 3.The case which is due to perform an additional positive inspection and medical treatment when diagnosis does not stick by bronchoscope inspection 4.Written informed consent
Key exclusion criteria	1.Visible by bronchoscopy 2.Lesions deemed as benign diseases on chest CT
Target sample size	15

Research contact person
Name of lead principal investigator	Fumio Imamura
Organization	osaka medical center for cancer and cardiovascular diseases
Division name	Department of Thoracic Oncology
Address	1-3-3, Nakamichi, Higashinari-ku, osaka,537-8511
TEL	06-6972-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	Takako Inoue
Organization	osaka medical center for cancer and cardiovascular diseases
Division name	Department of Thoracic Oncology
Address	1-3-3, Nakamichi, Higashinari-ku, osaka,537-8511
TEL	06-6972-1181
Homepage URL
Email	okuyama-ta@mc.pref.osaka.jp

Sponsor
Institute	osaka medical center for cancer and cardiovascular diseases
Institute
Department

Funding Source
Organization	osaka medical center for cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka University Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪府立成人病センター(大阪府)、大阪大学大学院医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 16 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 08 Day
Anticipated trial start date	2014 Year 05 Month 08 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 16 Day
Last modified on	2016 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016346