UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016450
Receipt number R000019109
Scientific Title Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study
Date of disclosure of the study information 2015/02/05
Last modified on 2015/02/05 16:18:55

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Basic information

Public title

Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study

Acronym

Feasibility of a novel extra-wide-angle-view colonoscope

Scientific Title

Feasibility of a novel extra-wide-angle-view colonoscope: a clinical study

Scientific Title:Acronym

Feasibility of a novel extra-wide-angle-view colonoscope

Region

Japan


Condition

Condition

colorectal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of a novel colonoscope.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety of a novel colonoscope

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

no symptom (screening, FIT(+), PET(+)),
symptom (abd. pain, melena/anal bleeding)

Key exclusion criteria

acute colitis, inflammatory bowel syndrome, post colorectomy.

Target sample size

50


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

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

Okayama University Hospital

Division name

Department of Endoscopy

Zip code


Address

2-5-2, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7219

Homepage URL


Email

toshi_urao@yahoo.co.jp


Sponsor or person

Institute

Hiroshima University, Okayama University, National Cancer Center, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

non

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

岡山大学病院、広島大学病院


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially 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

2010 Year 02 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 15 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

2015 Year 02 Month 05 Day

Last modified on

2015 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019109


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name