UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044292 |
|---|---|
| Receipt number | R000050594 |
| Scientific Title | The usefulness of colon capsule endoscopy monitoring in ulcerative colitis |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/06/02 13:41:44 |
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Basic information
Public title
The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Acronym
The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Scientific Title
The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Scientific Title:Acronym
The usefulness of colon capsule endoscopy monitoring in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of colon capsule endoscopy as a next-generation screening test for mucosal healing of ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the diagnostic ability of colon capsule endoscopy using the mucosal healing / activity scale for ulcerative colitis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Colon capsule endoscopy in patients with ulcerative colitis
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 18 to 80
2) Those who can fully understand this clinical study and obtain consent
Key exclusion criteria
1) Dysphagia
2) Equipped with a pacemaker
3) Women who are pregnant or may become pregnant
4) Intestinal stenosis (small intestine / large intestine)
5) Allergies to various laxatives
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoriaki |
| Middle name | |
| Last name | Komeda |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
TEL
072-366-0221
y-komme@mvb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Masaki |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
TEL
072-366-0221
Homepage URL
sho1110sho1110@yahoo.co.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2 Ohnohigashi, Osaka-Sayama City, Osaka 589-8511, Japan
Tel
072-366-0221
y-komme@mvb.biglobe.ne.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
| 2021 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050594
