UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056375 |
|---|---|
| Receipt number | R000064414 |
| Scientific Title | Prospective observational study on enteroscopy for small intestinal diseases |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2025/12/15 12:50:37 |
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Basic information
Public title
Prospective observational study on enteroscopy for small intestinal diseases
Acronym
Prospective observational study on enteroscopy for small intestinal diseases
Scientific Title
Prospective observational study on enteroscopy for small intestinal diseases
Scientific Title:Acronym
Prospective observational study on enteroscopy for small intestinal diseases
Region
| Japan |
Condition
Condition
Crohn's disease, small intestine bleeding, small intestine tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate and characterize the outcomes of endoscopic practice for small bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of adverse events caused by enteroscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit our outpatient clinic between the date of approval from the head of the research institution and February 2030, are diagnosed with small intestinal disease, and undergo small intestinal endoscopy using a Fujifilm endoscope, and who have given their free and voluntary informed consent for this study are eligible to participate.
Key exclusion criteria
(1) Cases in which the patient is incapable of consenting due to a minor or dementia, etc.
(ii) Other cases that the physician in charge deems inappropriate for enrollment
(iii) Cases in which the subject refuses to participate in the study after enrollment in the stud
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
marimizutani6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Fujifilm Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
marimizutani6@keio.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
| 2024 | Year | 12 | Month | 06 | 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
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2035 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subject Background
Demographic information, date of birth, gender
Lifestyle habits and preferences, smoking and drinking history
Medical history medical history, complications, allergies
Physical findings
Vitals, body temperature, blood pressure, pulse, respiratory rate, oxygen saturation
Height and weight
Confirmation of adverse events, check for side effects and other adverse events
Confirmation of concomitant medication
Clinical examination
Hematological examination
Red blood cell count, white blood cell count, hemoglobin, hematocrit, platelet count, white blood cell fraction
Blood biochemical tests
Total protein, albumin, total bilirubin, AST, ALT, LDH, ALP, urea nitrogen, creatinine, sodium, potassium, chlor, calcium, phosphorus, blood sugar, hemoglobin A1C, total cholesterol, LDL cholesterol, HDL cholesterol, LRG, CRP
Endoscopy
Radiographic examination
CT
Pathological findings
Degree of adverse events
Presence or absence of additional treatment
Recurrence or not
Medical expenses
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064414
