UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059711 |
|---|---|
| Receipt number | R000068163 |
| Scientific Title | Diagnostic Accuracy of the Bowel Wall Flow Assessed by MV-Flow in Detecting Inflammation Severity in Ulcerative Colitis: A Comparative Study with Endoscopic Severity (FLOW Trial) |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 06:59:08 |
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Basic information
Public title
Diagnostic Accuracy of the Bowel Wall Flow Assessed by MV-Flow in Detecting Inflammation Severity in Ulcerative Colitis: A Comparative Study with Endoscopic Severity (FLOW Trial)
Acronym
Diagnostic Accuracy of the Bowel Wall Flow Assessed by MV-Flow in Detecting Inflammation Severity in Ulcerative Colitis: A Comparative Study with Endoscopic Severity (FLOW Trial)
Scientific Title
Diagnostic Accuracy of the Bowel Wall Flow Assessed by MV-Flow in Detecting Inflammation Severity in Ulcerative Colitis: A Comparative Study with Endoscopic Severity (FLOW Trial)
Scientific Title:Acronym
Diagnostic Accuracy of the Bowel Wall Flow Assessed by MV-Flow in Detecting Inflammation Severity in Ulcerative Colitis: A Comparative Study with Endoscopic Severity (FLOW Trial)
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the modified Limberg score with the newly developed MV Flow score for assessing disease severity in UC using MV flow technology. The goal is to determine whether MV flow can offer superior diagnostic accuracy and better reflect the inflammatory status of the intestinal mucosa.
Basic objectives2
Others
Basic objectives -Others
In the routine clinical practice of performing colonoscopy on UC patients, we will use Samsung's ultrasound device for research purposes to conduct IUS as an additional test. Patients will be asked to provide stool samples before or after the examination for measuring fecal calprotectin.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study is to create a validated scoring system using MV-Flow to assess the endoscopic severity in patients with UC. This involves the creation of a scoring system based on the localization and shape of blood flow signals in the mucosa, submucosa, and muscularis propria, as well as the assessment of the proportion of blood vessels within the wall (using vascularity indices, which were the ratio (%) of color pixels in the total grayscale pixels in a defined region of interest) and the degree of blood flow using a VAS scale.
Key secondary outcomes
Comparison of the Modified Limberg score with the assessment of inflammation evaluated by endoscopic and histological findings.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive patients more than 15 years old who have a UC undergoing endoscopy for evaluation of disease activity or surveillance were eligible for inclusion.
Key exclusion criteria
If there was a change in treatment or symptoms between IUS and endoscopy, patients were excluded. Patients with a history of total colectomy and pregnant women were also excluded.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
Tokyo, Minato-Ku, Shirokane, 5-9-1
TEL
0334446161
drkobataku@gmail.com
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced Treatment of Inflammatory Bowel Disease
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
0334446161
Homepage URL
drkobataku@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
SAMSUNG
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
Kitasato University Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
0357916106
kenkyu@insti.kitasato-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
| 2025 | Year | 11 | Month | 10 | 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
70
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the routine clinical practice of performing colonoscopy on UC patients, we will use Samsung's ultrasound device for research purposes to conduct IUS as an additional test. Patients will be asked to provide stool samples before or after the examination for measuring fecal calprotectin.
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068163
