UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018309 |
|---|---|
| Receipt number | R000021177 |
| Scientific Title | Investigation for gastrointestinal mucosa and submucosa using new endoscopic imaging technology (Dual Red Imaging) |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2023/01/07 21:40:24 |
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Basic information
Public title
Investigation for gastrointestinal mucosa and submucosa using new endoscopic imaging technology (Dual Red Imaging)
Acronym
Investigation for gastrointestinal mucosa and submucosa using Dual Red Imaging
Scientific Title
Investigation for gastrointestinal mucosa and submucosa using new endoscopic imaging technology (Dual Red Imaging)
Scientific Title:Acronym
Investigation for gastrointestinal mucosa and submucosa using Dual Red Imaging
Region
| Japan |
Condition
Condition
Esophageal cancer, Esophageal intraepithelial neoplasia,gastric cancer, gastric adenoma, colorectal cancer, colorectal adenoma, Barrett's esophageal cancer, ulcerative colitis, esophageal varices
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1.Efficacy for endoscopic diagnosis
2.Efficacy for endoscopic submucosal dissection (ESD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Improvement of diagnosis precision: Detection for lesion, Diagnosis of depth of cancer invasion, Assessment for the severity of inflammation.
2.Improvement for visualization of thick blood vessel and bleeding point during ESD. Shortening of total ESD procedure time.
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
Diagnosis 80 cases, ESD 120 cases
Period:From March 20 2014 until April 30 2016
We perform diagnosis or ESD of each case using DRI.
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
1. Patient for esophageal cancer, gastric cancer,gastric adenoma, colorectal cancer,colorectal adenoma, Barrett's esophageal cancer, esophageal varices
2. Patient that an agreement was obtained.
Key exclusion criteria
1. Patient who has other disease which affect this study such as severe ulcer or inflammation.
2. The patient who judged that we were inappropriate to perform examination safely.
3. Patient that an agreement was not obtained.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Yahagi |
Organization
Keio University
Division name
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3437
yahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Yahagi |
Organization
Keio University
Division name
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3437
Homepage URL
yahagi-tky@umin.ac.jp
Sponsor or person
Institute
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Institute
Department
Personal name
Funding Source
Organization
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio 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
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
| 2015 | Year | 07 | Month | 15 | 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
DRI improved easiness of hemostasis and dicreased psycological stress on hemostasis and time required for hemostasis. (Presentation at the 89th congress of the Japan Gastroenterological Endoscopy Society, May 2015)
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
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 01 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021177
