UMIN-CTR Clinical Trial

Basic information
Public title	Total Observation from intestine To Anal Lesion study
Acronym	TOTAL study
Scientific Title	Total Observation from intestine To Anal Lesion study
Scientific Title:Acronym	TOTAL study
Region	Japan

Condition
Condition	(suspicion of) colon diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	examination of the added value of total observation from intestine to rectum using colon capsule endoscopy
Basic objectives2	Others
Basic objectives -Others	examination of efficacy and safety of colon capsule endoscopy
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	capsule endoscopic findings
Key secondary outcomes	rate of total colon observation, rate of detection of abnormal findings, receptivity of colon capsule endoscopy

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	subjects who were informed, and consented to this study.
Key exclusion criteria	diagnosed Crohn's disease, radiation colitis with stricture
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroto Hiraga
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Gastroenterology and hematology
Zip code
Address	5 Zaifu-cho, Hirosaki, Japan
TEL	0172-39-5053
Email	hhiraga-gi@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroto Hiraga
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Gastroenterology and hematology
Zip code
Address	5 Zaifu-cho, Hirosaki, Japan
TEL	0172-39-5053
Homepage URL
Email	hhiraga-gi@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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 07 Month 01 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	Preinitiation
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	no information

Management information
Registered date	2017 Year 06 Month 03 Day
Last modified on	2017 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031614

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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