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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028264
Receipt No. R000032345
Scientific Title Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases
Date of disclosure of the study information 2017/07/17
Last modified on 2017/07/17

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Basic information
Public title Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases
Acronym Capsule endoscopy and double-balloon enteroscopy
Scientific Title Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases
Scientific Title:Acronym Capsule endoscopy and double-balloon enteroscopy
Region
Japan

Condition
Condition Small-bowel diseases
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the usefulness and the adverse events of capsule endoscopy and double-balloon enteroscopy retrospectively and prospectively for small-bowel diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Usefulnessof capsule endoscopy and double-balloon enteroscopy
Key secondary outcomes Adverse events of capsule endoscopy 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with documented or suspected small-bowel diseases
Key exclusion criteria Patients without indications of double-balloon enteroscopy and capsule endoscopy.
Target sample size 1500

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, Toyoake, Aichi 470-1192
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, Toyoake, Aichi 470-1192
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
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 Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
2017 Year 07 Month 17 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
Diagnostic yields of double-balloon enteroscopy and capsule endoscopy
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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 10 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information Adverse events of double-balloon enteroscopy and capsule endoscopy

Management information
Registered date
2017 Year 07 Month 17 Day
Last modified on
2017 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032345

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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