UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020448
Receipt number R000022988
Scientific Title Detectability of colorectal lesions using the novel endoscopic system which 330 degrees wide viewing angle was wquipped with: a multicenter randomized controlled trial
Date of disclosure of the study information 2016/01/07
Last modified on 2018/07/09 14:42:46

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Basic information

Public title

Detectability of colorectal lesions using the novel endoscopic system which 330 degrees wide viewing angle was wquipped with: a multicenter randomized controlled trial

Acronym

Detectability of colorectal lesions using the novel endoscopic system which 330 degrees wide viewing angle was wquipped with: a multicenter randomized controlled trial (FUSE STUDY)

Scientific Title

Detectability of colorectal lesions using the novel endoscopic system which 330 degrees wide viewing angle was wquipped with: a multicenter randomized controlled trial

Scientific Title:Acronym

Detectability of colorectal lesions using the novel endoscopic system which 330 degrees wide viewing angle was wquipped with: a multicenter randomized controlled trial (FUSE STUDY)

Region

Japan


Condition

Condition

colorectal lesions

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the miss rates of colorectal lesions using the Fuse (full spectrum endoscopy) system of wide viewing angle colonoscope with the conventional forward-viewing colonoscope.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The miss rates of colorectal adenomatous lesions

Key secondary outcomes

The miss rates of colorectal any lesions
The number of detected colorectal adenomatous lesions
The number of detected colorectal any lesions
Procedure time


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Wide viewing angle colonoscope
Study period: one year

Interventions/Control_2

Conventional forward-viewing colonoscope
Study period: one year

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients whom colonoscopy is performed in for the first time

The patients who had been treated all colon polyps before and that it has been judged that there was no information about their polyps

Key exclusion criteria

Inflammatory bowel disease

Familial adenomatous pplyposis

The patients with a history of colorectal surgical resection

The patients with the haemorrhage of digestive tract

Colonic stenosis

Acute diverticulitis

Toxic megacolon

Target sample size

340


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sin-ei Kudo

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1 Chigasaki Chuo Tsuzuki-ku Yokohama-city Kanagawa 224-8503 Japan

TEL

045-949-7000

Email

kudos@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyoki Kudo

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1 Chigasaki Chuo Tsuzuki-ku Yokohama-city Kanagawa 224-8503 Japan

TEL

045-949-7000

Homepage URL


Email

s6027@nms.ac.jp


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

Adachi Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

1)Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
2)Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
3)Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan
4)Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
5)Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
6)Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University, Osaka, Japan
7)Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan
8)Department of Endoscopy, Jikei University School of Medicine, Tokyo, Japan


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 07 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

2015 Year 11 Month 16 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 18 Day

Last follow-up date


Date of closure to data entry

2017 Year 02 Month 24 Day

Date trial data considered complete

2017 Year 02 Month 24 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 06 Day

Last modified on

2018 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022988


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/02/24 FUSE:解析(UMIN登録用).xlsx