UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025867 |
|---|---|
| Receipt number | 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 00:06:12 |
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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
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
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine department of gastroenterology and hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029740
