UMIN-CTR Clinical Trial

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