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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028694
Receipt No. 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 2019/08/21

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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
Email 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
Email y-komme@mvb.biglobe.ne.jp

Sponsor
Institute Kindai 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

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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 16 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032809

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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