UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Novel endoscopic views of colorectal neoplastic lesions by new endoscopic system using LASER source
Title of the study (Brief title)	LASER endoscopy to colorectal tumors
Region	Japan

Condition
Condition	colorectal tumors
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To claryfy the effect of LASER endoscope for diagnosis of colorectal tumor, compared to NBI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	To caluculate the agreement of classification to colorectal tumors between LASER endoscpe and NBI according to NBI classification.
Key secondary outcomes	To compare the endoscopic diagnosis by LASER endoscope and histopathological diagnosis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To diagnose colorectal tumors by two modality such as LASER endoscope and NBI
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	colorectal tumors diagnosed histopathlogically
Key exclusion criteria	to exclude cases with disorder of main organs
Target sample size	100

Research contact person
Name of lead principal investigator	NaohisaYoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email

Public contact
Name of contact person	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	naohisa@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Fukuoka University Chikushi 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	京都府立医科大学附属病院（京都府） 福岡大学筑紫病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 01 Month 01 Day
Date trial data considered complete	2013 Year 02 Month 01 Day
Date analysis concluded	2013 Year 03 Month 01 Day

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

Management information
Registered date	2012 Year 02 Month 15 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008610