UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of Image enhanced endoscopy(IEE) for ACF observation
Title of the study (Brief title)	Usefulness of Image enhanced endoscopy(IEE) for ACF observation
Region	Japan

Condition
Condition	A person having colorectal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical utility of IEE, NBI and BLI, for detection of rectal ACF.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of rectal ACF
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	colonoscopy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	A person having colorectal tumor (adenoma or carcinoma) history
Key exclusion criteria	1) A person who underwent surgical resection of rectum 2) Those who are taking anti-thrombotic agents such as, Aspirin, Ticlopidine, Hydrochloride, Warfarin potassium, Dipyridamole. 3) A person of inflammatory bowel disease
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsuji Takayama
Organization	Tokushima University Graduate School, The Institute of Biomedical Sciences
Division name	Department of Gastroenterology and Oncology
Address	3-18-15, Kuramoto-cho, Tokushima city
TEL	088-633-7122
Email	takayama@tokushima-u.ac.jp

Public contact
Name of contact person	Kaizo kagemoto
Organization	Tokushima University Graduate School, The Institute of Biomedical Sciences
Division name	Department of Gastroenterology and Oncology
Address	3-18-15, Kuramoto-cho, Tokushima city
TEL	088-633-7122
Homepage URL
Email	kage1733@yahoo.co.jp

Sponsor
Institute	Tokushima University Hospital, Department of Gastroenterology and Oncology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokushima University Hospital, Department of Gastroenterology and Oncology
Organization
Division
Category of Funding Organization	Non profit foundation
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	2016 Year 05 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 16 Day
Anticipated trial start date	2016 Year 05 Month 16 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	2016 Year 05 Month 16 Day
Last modified on	2016 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025720