UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043453 |
|---|---|
| Receipt number | R000049624 |
| Scientific Title | A Study on the Effectiveness of Imaged Enhanced Endoscopy in Eosinophilic Esophagitis |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/02/27 10:09:39 |
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Basic information
Public title
A Study on the Effectiveness of Imaged Enhanced Endoscopy in Eosinophilic Esophagitis
Acronym
A Study on the Effectiveness of Imaged Enhanced Endoscopy in Eosinophilic Esophagitis
Scientific Title
A Study on the Effectiveness of Imaged Enhanced Endoscopy in Eosinophilic Esophagitis
Scientific Title:Acronym
A Study on the Effectiveness of Imaged Enhanced Endoscopy in Eosinophilic Esophagitis
Region
| Japan |
Condition
Condition
Eosinophilic esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the contribution of IEE to the endoscopic diagnosis of eosinophilic esophagitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lesion detection rate
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with symptoms related to dysphagia who are suspected to have eosinophilic esophagitis, or patients who have been diagnosed with eosinophilic esophagitis and are under observation.
Key exclusion criteria
Patients with a tendency to bleed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Ayaki |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
7008505
Address
Kita-ku,Nakasange,Okayama-city
TEL
81-86-225-2111
mkmnb1979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Ayaki |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
7008505
Address
Kita-ku,Nakasange,Okayama-city
TEL
81-86-225-2111
Homepage URL
mkmnb1979@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki medical school
Address
Kita-ku,Nakasange,Okayama-city
Tel
81-86-225-2111
mkmnb1979@yahoo.co.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 | 04 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with confirmed or suspected eosinophilic esophagitis will undergo IEE observation to determine if there is any difference in the detection rate of lesions compared to normal light observation.
Management information
Registered date
| 2021 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049624
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
