UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020135 |
|---|---|
| Receipt number | 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 10:42:17 |
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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
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
shokakan@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023259
