UMIN-CTR Clinical Trial

Basic information
Public title	Bowel preparation for colon capsule endoscopy examination
Acronym	Bowel preparation for colon capsule endoscopy examination
Scientific Title	Bowel preparation for colon capsule endoscopy examination
Scientific Title:Acronym	Bowel preparation for colon capsule endoscopy examination
Region	Japan

Condition
Condition	colorectal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development of minimun preparation for colorectal capsule endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	quality of colorectal capsule endoscopy
Key secondary outcomes	patients satisfaction

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patient has the indication for colorecatal capsule endoscopy examination.
Key exclusion criteria	patients has some risks on the examinations: stenosis, ileus, severe constipations.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Matsumoto
Organization	Kawawasaki Medical School
Division name	Division of Gastroenterology
Zip code
Address	Matsushima 577, Kurashiki city, Okayamama
TEL	086-462-1111
Email	hmatsumoto0311@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Matsumoto
Organization	Kawawasaki Medical School
Division name	Division of Gastroenterology
Zip code
Address	Matsushima 577, Kurashiki city, Okayamama
TEL	086-462-1111
Homepage URL
Email	hmatsumoto0311@gmail.com

Sponsor
Institute	Kawawasaki Medical School
Institute
Department

Funding Source
Organization	Kawawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Okayama University, Okayama general city medical center, Okayama medical center,Hiroshima University, Yamaguchi University, sainthill hospital, Matsue red cross hospital, Tottori university, Kagawa prefetural centaral hospital, Takamatsu hospital, Hyogo collage of medicine
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	2015 Year 08 Month 08 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	2015 Year 08 Month 01 Day
Date of IRB	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	we have a plan to check the first protocol at the time 20 cases observation.

Management information
Registered date	2015 Year 08 Month 08 Day
Last modified on	2020 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019837