UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008718
Receipt number R000010174
Scientific Title A novel colonoscope for colorectal polyp detection: a multicenter study
Date of disclosure of the study information 2012/08/17
Last modified on 2016/09/05 22:21:07

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Basic information

Public title

A novel colonoscope for colorectal polyp detection: a multicenter study

Acronym

A novel colonoscope for colorectal polyp detection: a multicenter study

Scientific Title

A novel colonoscope for colorectal polyp detection: a multicenter study

Scientific Title:Acronym

A novel colonoscope for colorectal polyp detection: a multicenter study

Region

Japan


Condition

Condition

colorectal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of a novel colonoscope for the detection of colorectal lesions

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Detection rate of colorectal neoplastic lesions using a a novel colonoscope

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

A novel colonoscope group

Interventions/Control_2

Standard colonoscope group

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Colorectal cancer screening or polyp surveillance.

Key exclusion criteria

Patients with genetic syndromes such as hereditary non-polypoid colon cancer (HNPCC) and familial adenomatous polyposis; inflammatory bowel disease; active bleeding; or a previous colonic resection.

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Tanaka

Organization

Hiroshima University Hospital

Division name

Department of Endoscopy

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5538

Email

colon@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Uraoka

Organization

School of Medicine, Keio University

Division name

Division of Research and Development for Minimally Invasive Treatment, Cancer Center

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3437

Homepage URL


Email

turaoka@a3.keio.jp


Sponsor or person

Institute

Kyushu University, Keio University, National Cancer Center Hospital, Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

九州大学(福岡県)、慶應義塾大学(東京都)、国立がん研究センター中央病院(東京都)、広島大学(広島県)


Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2012 Year 11 Month 11 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 17 Day

Last modified on

2016 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name