UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bronchoscopy with new NBI (Narrow Band Imaging) system
Title of the study (Brief title)	Bronchoscopy with new NBI (Narrow Band Imaging) system
Region	Japan

Condition
Condition	Lung Lesion(s) Requiring Evaluation
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate outcomes following Bronchoscopy using the new Narrow Band Imaging (NBI) system
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnostic yields
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Bronchoscopy using the new Narrow Band Imaging (NBI) system
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All cases for whom bronchoscopy is performed 1) Diagnosis of pulmonary disease. 2) Written informed consent. 3) Bronchoscopy is indicated.
Key exclusion criteria	Contraindications for bronchoscopy 1) Uncontrolled severe allergies. 2) Organ failure and sepsis. 3) Severe respiratory failure. 4) Any other reason in the judgement of the inversigator to interfere with participation & compliance with protocol.
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshihiro Kazebayashi
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	+81-166-69-3290
Email	kazeba@asahikawa-med.ac.jp

Public contact
Name of contact person	Yoshihiro Kazebayashi
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	+81-166-69-3290
Homepage URL
Email	kazeba@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 01 Month 12 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029367