UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022322
Receipt number R000025720
Scientific Title Usefulness of Image enhanced endoscopy(IEE) for ACF observation
Date of disclosure of the study information 2016/05/16
Last modified on 2016/05/17 14:25:39

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Basic information

Public title

Usefulness of Image enhanced endoscopy(IEE) for ACF observation

Acronym

Usefulness of Image enhanced endoscopy(IEE) for ACF observation

Scientific Title

Usefulness of Image enhanced endoscopy(IEE) for ACF observation

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Tetsuji Takayama

Organization

Tokushima University Graduate School, The Institute of Biomedical Sciences

Division name

Department of Gastroenterology and Oncology

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima city

TEL

088-633-7122

Email

takayama@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaizo kagemoto

Organization

Tokushima University Graduate School, The Institute of Biomedical Sciences

Division name

Department of Gastroenterology and Oncology

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima city

TEL

088-633-7122

Homepage URL


Email

kage1733@yahoo.co.jp


Sponsor or person

Institute

Tokushima University Hospital, Department of Gastroenterology and Oncology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2016 Year 05 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025720


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name