UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007304
Receipt number R000008610
Scientific Title Novel endoscopic views of colorectal neoplastic lesions by new endoscopic system using LASER source
Date of disclosure of the study information 2012/02/20
Last modified on 2018/09/05 20:37:16

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Basic information

Public title

Novel endoscopic views of colorectal neoplastic lesions by new endoscopic system using LASER source

Acronym

LASER endoscopy to colorectal tumors

Scientific Title

Novel endoscopic views of colorectal neoplastic lesions by new endoscopic system using LASER source

Scientific Title:Acronym

LASER endoscopy to colorectal tumors

Region

Japan


Condition

Condition

colorectal tumors

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To claryfy the effect of LASER endoscope for diagnosis of colorectal tumor, compared to NBI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

To caluculate the agreement of classification to colorectal tumors between LASER endoscpe and NBI according to NBI classification.

Key secondary outcomes

To compare the endoscopic diagnosis by LASER endoscope and histopathological diagnosis


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

To diagnose colorectal tumors by two modality such as LASER endoscope and NBI

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

colorectal tumors diagnosed histopathlogically

Key exclusion criteria

to exclude cases with disorder of main organs

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name NaohisaYoshida

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naohisa Yoshida

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

naohisa@koto.kpu-m.ac.jp


Sponsor or person

Institute

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Fukuoka University Chikushi Hospital

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

京都府立医科大学附属病院(京都府)
福岡大学筑紫病院(福岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 20 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

Completed

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2013 Year 01 Month 01 Day

Date trial data considered complete

2013 Year 02 Month 01 Day

Date analysis concluded

2013 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 15 Day

Last modified on

2018 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=R000008610


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name