UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038163 |
|---|---|
| Receipt number | R000043501 |
| Scientific Title | Single-center prospective observational study on the usefulness of Top 100 features of capsule endoscopy |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2020/02/25 12:54:01 |
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Basic information
Public title
Single-center prospective observational study on the usefulness of Top 100 features of capsule endoscopy
Acronym
Prospective study of Top 100
Scientific Title
Single-center prospective observational study on the usefulness of Top 100 features of capsule endoscopy
Scientific Title:Acronym
Top 100 study
Region
| Japan |
Condition
Condition
Small and large bowel diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analysis the detection rates of lesions with top 100 features based on the conventional capsule endoscopy reading.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Comparison of detected numbers of lesions among conventional, quick-view, and top 100 reading of small bowel and colon capsule endoscopy
Key secondary outcomes
1. Comparison of time to diagnose with conventional, quick-view, and top 100 reading
2. Comparison of the numbers of overlooked lesions among conventional, quick-view, and top 100 reading
3. Comparison of capsule findings and conventional colonoscopy and double-balloon enteroscopy
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
| 10 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Consenting patients
Key exclusion criteria
Inappropirate patients such as small and large bowel stenotic diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Ikue |
| Middle name | |
| Last name | Tanigawa |
Organization
Fujita Health University
Division name
IRB
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562932860
Homepage URL
research@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
IRB
Address
1-98 Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel
0562932860
f-irb@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 25 | 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
Ongoing
Results date posted
| 2019 | Year | 09 | Month | 30 | Day |
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
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
detection rate of lesions, time to diagnosis, overlook rate
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
