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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025693
Receipt No. R000029559
Scientific Title Usefulness and adverse events of double-balloon enteroscopy and small bowel capsule endoscopy in small bowel diseases
Date of disclosure of the study information 2017/01/16
Last modified on 2017/01/16

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

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

Objectives
Narrative objectives1 Double-balloon enteroscopy and small bowel capsule endoscopy has been a breakthrough for the diagnosis and treatment of small bowel diseases. In this study, we retrospectively and prospectively analyzed the usefulness and adverse events for various small bowel diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Diagnostic yields of double-balloon enteroscopy and small bowel capsule endoscopy
Key secondary outcomes Adverse events of double-balloon enteroscopy and small bowel capsule endoscopy
Usefulness of vascular index based on comorbidities
Rebleeding rate
Prognosis

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
0 years-old <=
Age-upper limit
110 years-old >
Gender Male and Female
Key inclusion criteria Patients with suspected or documented small bowel diseases
Key exclusion criteria Patients with severe illness in whom double-balloon enteroscopy is contaraindication.
Target sample size 3000

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
TEL 0562939240
Email nohmya@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
TEL 0562939240
Homepage URL
Email nohmya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Self funding
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
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 藤田保健衛生大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 16 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
It is now ongoing study.
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
2003 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 06 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
2030 Year 05 Month 31 Day
Date trial data considered complete
2030 Year 05 Month 31 Day
Date analysis concluded
2030 Year 07 Month 31 Day

Other
Other related information NOne

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029559

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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