UMIN-CTR Clinical Trial

Basic information
Public title	Appropriate bowel preparation for colon capsule endoscopy
Acronym	CCE Regimen Study
Scientific Title	Appropriate bowel preparation for colon capsule endoscopy
Scientific Title:Acronym	CCE Regimen Study
Region	Japan

Condition
Condition	Colorectal disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the use of Gastrografin in the bowel preparation regimen for colon capsule endoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	GI tract transit time
Key secondary outcomes	colon transit time, capsule excretion rate, rescue rate, occurence rate of assosiated synptom, occurence rate of adverse event, detection rate of colorectal polyp, number of colorectal polyps detected.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Gastrografin administration
Interventions/Control_2	No Gastrografin administration
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who clinically need colon capsule endoscopy covered by health insurance in Japan
Key exclusion criteria	severe diverticular disease pregnacy or possible pregnancy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazutomo Middle name Last name Togashi
Organization	Fukushima Medical University Aizu Medical Center
Division name	Coloproctology
Zip code	969-3492
Address	Aizuwakamatsu-city, Fukushima
TEL	+81-242752100
Email	togashik@fmu.ac.jp

Public contact
Name of contact person	1st name Jinko Middle name Last name Kobayashi
Organization	Fukushima Medical University Aizu Medical Center
Division name	Administration
Zip code	969-3492
Address	Aizuwakamatsu-city, Fukushima
TEL	+81-242752100
Homepage URL
Email	jinko-kb@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	1 Hibarigaoka, Fukushima-city, Fukushima
Tel	+81-245471825
Email	rs@fmu.ac.jp

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	小樽掖済会病院消化器病センター（北海道）、北海道消化器科病院（北海道）、九州大学病院（福岡県）、東京医科歯科大学病院（東京都）、京都府立医科大学病院（京都府)、慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2014 Year 12 Month 12 Day
Date of IRB	2014 Year 12 Month 12 Day
Anticipated trial start date	2015 Year 01 Month 21 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 20 Day
Last modified on	2021 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018743