UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030027 |
|---|---|
| Receipt number | R000034289 |
| Scientific Title | Research on digestive tract disease database centering on capsule endoscopy |
| Date of disclosure of the study information | 2017/11/18 |
| Last modified on | 2018/05/31 17:38:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on digestive tract disease database centering on capsule endoscopy
Acronym
Research on digestive tract disease database centering on capsule endoscopy
Scientific Title
Research on digestive tract disease database centering on capsule endoscopy
Scientific Title:Acronym
Research on digestive tract disease database centering on capsule endoscopy
Region
| Japan |
Condition
Condition
Diseases associated with small bowel
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the capsule endoscope embodiment as a database and evaluate the effectiveness of examination / treatment, safety (accident), disease frequency, clinical picture and long-term prognosis (course)
Basic objectives2
Others
Basic objectives -Others
Establish academic evaluation in gastrointestinal disease.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Features of capsule endoscopic findings of each gastrointestinal disease
Key secondary outcomes
Clinical characteristics and treatment outcome of each gastrointestinal disease, long-term 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
| 10 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who sufficiently understood this research and gained consent
Key exclusion criteria
Patients who do not obtain consent to this study
Patients who judged that other researchers are not appropriate as research subjects
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tnakanari Kitazono |
Organization
Kyushu-University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
akharada@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Harada |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Homepage URL
akharada@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
Institute
Department
Personal name
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
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
| 2017 | Year | 11 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
registering now
Management information
Registered date
| 2017 | Year | 11 | Month | 18 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034289
