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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025867
Receipt No. R000029740
Scientific Title Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection
Date of disclosure of the study information 2017/02/01
Last modified on 2017/01/27

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Basic information
Public title Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection
Acronym Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection
Scientific Title Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection
Scientific Title:Acronym Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection
Region
Japan

Condition
Condition Gastric tumor
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy for Visualization of Bleeding Points in endoscopic submucosal dissection (ESD)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Assessment for Visualization of Bleeding Points by Linked Color Imaging compared with White Light Imaging(Operator)
Key secondary outcomes 1.Assessment for Video Visualization of Bleeding Points by Linked Color Imaging compared with White Light Imaging(Non operator)
2.Psycological stress(Operator)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients of gastric tumors who gave written informed consent
Key exclusion criteria The patients that an agreement is not obtained
The patients that doctor attending judged an arrangement to this study to be inadequate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Dohi
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Homepage URL
Email osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural university of medicine department of gastroenterology and hepatology
Institute
Department

Funding Source
Organization Kyoto prefectural university of medicine department of gastroenterology and hepatology
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigation for Efficacy of Linked Color Imaging for Clear Visualization of Bleeding Points in Endoscopic Submucosal Dissection

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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