UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051255 |
|---|---|
| Receipt number | R000052970 |
| Scientific Title | Efficacy of extended depth of field for diagnosis for diminutive colorectal polyps :a prospective trial |
| Date of disclosure of the study information | 2023/06/08 |
| Last modified on | 2024/03/04 17:19:17 |
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Basic information
Public title
Efficacy of extended depth of field for diagnosis for diminutive colorectal polyps
Acronym
Optical diagnosis of diminutive colorectal polyps using an endoscopy with extended depth of field
Scientific Title
Efficacy of extended depth of field for diagnosis for diminutive colorectal polyps
:a prospective trial
Scientific Title:Acronym
Optical diagnosis of diminutive colorectal polyps using an endoscopy with extended depth of field
:a prospective trial
Region
| Japan |
Condition
Condition
diminutive colorectal polyps
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of extended depth of field for diagnosis for diminutive colorectal polyps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The NPV of optical diagnosis for diminutive rectosigmoid polyps by narrow band imaging without activating magnifying endoscopy
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to be received endoscopic resection for colorectal polyps.
Key exclusion criteria
1. The patients who do not be given informed consent
2. The patients who have severe coagulopathy
3. The patients who have severe cardiac or pulmonary diseases
4. The patients with an inflammatory bowel disease
5. The patients with have history of polyposis syndrome
6. The patients who are evaluated inappropriate for the research.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | MAI |
| Middle name | |
| Last name | FUKUDA |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishishimbashi
TEL
03-0344-1111
maifukuda049@gmail.com
Public contact
Name of contact person
| 1st name | MAI |
| Middle name | |
| Last name | FUKUDA |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishishimbashi
TEL
03-0344-1111
Homepage URL
maifukuda049@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
33-184(10801)
Org. issuing International ID_1
33-184(10801)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
