UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037424
Receipt number R000042660
Scientific Title A randomized control trial of adenoma detection rate in Endo-wing-assisted colonoscopy versus transparent hood-assisted colonoscopy
Date of disclosure of the study information 2019/08/05
Last modified on 2022/01/14 21:28:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A randomized control trial of adenoma detection rate in Endo-wing-assisted colonoscopy versus transparent hood-assisted colonoscopy

Acronym

ADR in Endo-wing vs transparent hood-assisted colonoscopy

Scientific Title

A randomized control trial of adenoma detection rate in Endo-wing-assisted colonoscopy versus transparent hood-assisted colonoscopy

Scientific Title:Acronym

ADR in Endo-wing vs transparent hood-assisted colonoscopy

Region

Japan


Condition

Condition

Patients endergoing colonoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare detection rate of colonic adenoma in Endo-wing-assisted colonoscopy versus transparent hood-assisted colonoscopy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

adenoma detection rate

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Endo-wing-assisted colonoscopy

Interventions/Control_2

transparent hood-assisted colonoscopy

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patinets undergoing colonoscpy

Key exclusion criteria

ileus, stenosis, history of colonic operation, active IBD, deverticulitis, active bleeding, pregnancy, severe heart disease, severe liver and recnal dysfunction

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Imaeda

Organization

Saitama Medical University

Division name

Department of Gastroenterology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

TEL

049-276-1667

Email

imaedahi@saitama-med.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Imaeda

Organization

Saitama Medical University

Division name

Department of Gastroenterology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

TEL

049-276-1667

Homepage URL


Email

imaedahi@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

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

IRB committee, Saitama Medical University Hospital

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

Tel

049-276-2107

Email

hirb@saitama-med.ac.jp


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

2019 Year 08 Month 05 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

800

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

2019 Year 07 Month 18 Day

Date of IRB

2019 Year 09 Month 10 Day

Anticipated trial start date

2019 Year 09 Month 20 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2031 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 07 Month 19 Day

Last modified on

2022 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042660


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name