UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028694 |
|---|---|
| Receipt number | R000032809 |
| Scientific Title | A prospective study on colon capsule endoscopy using caster oil |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2021/03/04 07:51:59 |
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Basic information
Public title
A prospective study on colon capsule endoscopy using caster oil
Acronym
A prospective study on colon capsule endoscopy using caster oil
Scientific Title
A prospective study on colon capsule endoscopy using caster oil
Scientific Title:Acronym
A prospective study on colon capsule endoscopy using caster oil
Region
| Japan |
Condition
Condition
Colon disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to use castor oil as a booster for colon capsule endoscopy and to verify capsule excretion rate, transit time of capsule excretion, and bowel cleansing level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
capsule excretion rate, transit time of capsule excretion, bowel cleansing level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Caster Oil
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with confirmed or suspicious of harboring colorectal disease
Key exclusion criteria
Patients with dysphasia
Patients with allergy to drugs used in this study
Pregnant or possible pregnant women
Patients who undergo MRI 2 weeks after CCE
Patients with present or past history of small and large bowel obstruction
Patients suspicious of having colorectal advanced carcinoma by tumor markers or symptoms
Patients inappropriate for this study by other reasons judged by investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoriaki Komeda |
Organization
Kindai University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama
TEL
072-366-0221
y-komme@mvb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoriaki Komeda |
Organization
Kindai University Faculty of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama
TEL
072-366-0221
Homepage URL
y-komme@mvb.biglobe.ne.jp
Sponsor or person
Institute
Kindai University
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 | 08 | Month | 31 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032809
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
