UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036359 |
|---|---|
| Receipt number | R000041425 |
| Scientific Title | Prospective study of image acquisition time using ultra-magnifying endoscopy |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/05/05 09:40:13 |
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Basic information
Public title
Examination of image acquisition time using ultra-magnifying endoscopy
Acronym
Examination of image acquisition time
Scientific Title
Prospective study of image acquisition time using ultra-magnifying endoscopy
Scientific Title:Acronym
Prospective study of image acquisition time
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the time to acquire ultra-magnifying images for evaluating inflammatory activity in ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
Ultra-magnifying endoscopy has two methods for the image acquisition :NBI method and staining method. We will evaluate whether the NBI method can acquire images in a shorter time than the staining method.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superiority (shorter time) to the staining method of the NBI method
Key secondary outcomes
Superiority (shorter time) to biopsy of the NBI method
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
Patients with ulcerative colitis who are clinically required to undergo colonoscopy at the Showa University Northern Yokohama Hospital.
Key exclusion criteria
Patients who did not obtain consent for study participation
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tuduki-ku Yokohama
TEL
+81459497000
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tuduki-ku Yokohama
TEL
+81459497000
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Kanagawa-ken
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital IRB
Address
35-1 Chigasakichuo Tuduki-ku Yokohama
Tel
+81459497000
irb02syh@ofc.showa-u.ac.jp
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
| 2019 | Year | 03 | Month | 31 | 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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Time required to acquire 5 images with NBI method
2.Time required to acquire 5 images by staining method
3.Time required to obtain 1 biopsy sample
We will compare 1 with 2 and 3.
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041425
