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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038163
Receipt No. 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

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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
Email 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
Email research@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Department of Gastroenterology
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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