UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050144 |
|---|---|
| Receipt number | R000057098 |
| Scientific Title | An Observation study for investing the relationship between hypoxia imaging endoscopy and the density of bile acid in colon, and clinical symptoms |
| Date of disclosure of the study information | 2023/01/26 |
| Last modified on | 2023/07/22 22:41:14 |
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Basic information
Public title
An Observation study for investing the relationship between hypoxia imaging endoscopy and the density of bile acid in colon, and clinical symptoms
Acronym
An observation study for the relationship between hypoxia imaging endoscopy and the density of bile acid in colon, and clinical symptoms
Scientific Title
An Observation study for investing the relationship between hypoxia imaging endoscopy and the density of bile acid in colon, and clinical symptoms
Scientific Title:Acronym
An Observation study for investing the relationship between hypoxia imaging endoscopy and the density of bile acid in colon, and clinical symptoms
Region
| Japan |
Condition
Condition
Abnormal defecation due to high or low bile acid
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the bilirubin signal value in the intestinal tract detected using the novel endoscopy system EP-0002 is consistent with the intestinal fluid bilirubin concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between bile pixel values measured in image enhancement mode and bile concentration in intestinal fluid
Key secondary outcomes
Correlation between pixel values measured in image enhancement mode and abdominal symptoms
Correlation between pixel values measured in image-enhanced mode and blood bile markers
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Undergo lower gastrointestinal endoscopy
2) Patients with no history of gastrointestinal surgery including cholecystectomy
Key exclusion criteria
(1) Inability to obtain written consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama Kanagawa
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama Kanagawa
TEL
0457872640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yokohama City University Hopspital IRB
Address
3-9 Fukuura Kanazawa Yokohama Kanagawa
Tel
045-370-7627
rinri@yokohama-cu.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
| 2023 | Year | 01 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observation study
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057098
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
