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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010513
Receipt No. R000012296
Scientific Title JACE appropriate use survey for patency capsule study
Date of disclosure of the study information 2013/04/17
Last modified on 2016/12/09

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Basic information
Public title JACE appropriate use survey for patency capsule study
Acronym J-POP Study
Scientific Title JACE appropriate use survey for patency capsule study
Scientific Title:Acronym J-POP Study
Region
Japan

Condition
Condition The patients who performed patency capsule in the research cooperation institutions.
Classification by specialty
Gastroenterology Gastrointestinal surgery Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the background, clinical outcome and adverse events in patient who performed patency capsule.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the clinical backgrounds and contents of examination in patients who were performed patency capsule. (primary survey)
Key secondary outcomes To evaluate the efficacies and issues of patency capsule and following capsule endoscopy for the medical practice in patients with Crohns disease. (for patients in primary survey)
To evaluate adverse events for patency capsule precisely. (for patients in additional survey in addition to primary survey)

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 The patients who performed patency capsule in the research cooperation institutions.
Key exclusion criteria The patients who were had allergy for barium. The patients who were judged as inadequate by the physician.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Matsui
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address Zokumyoin 1-1-1, Chikushino, Fukuoka
TEL 092-921-1011
Email matsui@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address Asahimachi 1-4-3, Abeno-ku, Osaka
TEL 06-6645-3811
Homepage URL
Email kenjiw@med.osaka-cu.ac.jp

Sponsor
Institute The Japanese Association for Capsule Endoscopy
Institute
Department

Funding Source
Organization The Japanese Association for Capsule Endoscopy
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 2410
Org. issuing International ID_1 Ethical committee in Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福岡大学筑紫病院(福岡県)、名古屋大学(愛知県)、大阪市立大学(大阪府)、他

Other administrative information
Date of disclosure of the study information
2013 Year 04 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
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 No longer recruiting
Date of protocol fixation
2012 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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 Prospective Study

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012296

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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