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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010732
Receipt No. R000011831
Scientific Title Prospective analysis for factors related to gastrointestinal peristalsis using capsule endoscopy
Date of disclosure of the study information 2013/05/16
Last modified on 2016/05/16

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Basic information
Public title Prospective analysis for factors related to gastrointestinal peristalsis using capsule endoscopy
Acronym Prospective analysis for factors related to gastrointestinal peristalsis
Scientific Title Prospective analysis for factors related to gastrointestinal peristalsis using capsule endoscopy
Scientific Title:Acronym Prospective analysis for factors related to gastrointestinal peristalsis
Region
Japan

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

Objectives
Narrative objectives1 to find the significant factor related to gastrointestinal movement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes significant factor related to gastrointestinal movement
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria paient with known or suspected small bowel disease
Key exclusion criteria 1: Patients with established retention or impaction of capsule endoscopy by the other examinations for small bowel
2: No bowel movements for over 4 days
3: Abdominal operated patients with difficulty to confirm safety to perform this investigation with the other examinations for small bowel
4: Subjects with pacemakers or other implanted electromedical devices
5: Swallowing disorder
6: Pregnant women
7: Patients with difficulty to perform the prescribed examinations
8: A serious patient
9: The patient who the physician judged as inappropriate
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2164
Email hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanao Nakamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 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
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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information transit time of capsule endoscopy

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2016 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011831

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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