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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020135
Receipt No. R000023259
Scientific Title Prospecive comparative study of comparison of detection rates and reading time between two different small-bowel capsule endoscopy, PillCam®SB3 and EC-S10
Date of disclosure of the study information 2015/12/09
Last modified on 2019/06/12

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Basic information
Public title Prospecive comparative study of comparison of detection rates and reading time between two different small-bowel capsule endoscopy, PillCam®SB3 and EC-S10
Acronym Double capsule study
Scientific Title Prospecive comparative study of comparison of detection rates and reading time between two different small-bowel capsule endoscopy, PillCam®SB3 and EC-S10
Scientific Title:Acronym Double capsule study
Region
Japan

Condition
Condition Established or suspected small bowel diseases
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the usefulness of adaptive frame rate between two capsule endoscopy with different frame rate function. To compare the diagnostic yields and reading time between beginners and expets.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Comparison of diagnostic yield of two different capsule endoscopy
Key secondary outcomes 1)Comparison of reading time of capsule endoscopy between beginners and expets
2)Comparison of diagnostic yield of capsule endoscopy between beginners and expets

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 PillCamSB3 followed by EC-S10
Interventions/Control_2 EC-S10 followed by PillCamSB3
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

Not applicable
Gender Male and Female
Key inclusion criteria Established or suspected small bowel diseases
Key exclusion criteria 1)Dysphagia
2)Pregnant
3)Small and large bowel obstruction
4)Plan to undergo MRI within 2 weeks
5)Judged as unsuitable by researchers
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-9240
Homepage URL
Email shokakan@fujita-hu.ac.jp

Sponsor
Institute Department of Gastroenterology, Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 09 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 Completed
Date of protocol fixation
2015 Year 12 Month 08 Day
Date of IRB
2015 Year 11 Month 12 Day
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 09 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023259

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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