UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer which is detected by colonoscopy
Title of the study (Brief title)	Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer
Region	Japan

Condition
Condition	Advanced colorectal cancers
Classification by specialty	Medicine in general Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of advanced colorectal cancer
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Colon capsule endoscopy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with advanced colorectal cancer,which is diagnosed by conventional colonoscopy
Key exclusion criteria	Patients with severe stenosis in the colon Patients with prior colectomy, colostomy or colonic stenting Patients with swallowing disorders Patients with pacemakers or other implanted electro medical devices Patients who could not perform surgery according to adverse general condition when complication was occurred Patients with allergy for polyethylene glycol, magnesium citrate, dimethicone, mosapride citrate, bisacodyl Patients with severe hepatic diseases Patients with severe renal diseases Patients with severe respiratory diseases Patients with severe cardiac diseases
Target sample size	20

Research contact person
Name of lead principal investigator	Atsuo Yamada
Organization	University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	yamada-a@umin.ac.jp

Public contact
Name of contact person	Atsuo Yamada
Organization	University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	yamada-a@umin.ac.jp

Sponsor
Institute	Department of Gastroentelorogy, University of Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Given imaging K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	東京大学医学部附属病院（東京都） University of Tokyo (Tokyo)

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 25 Day
Anticipated trial start date	2013 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014750