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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012962
Receipt No. R000014003
Scientific Title Prospective study for the diagnostic accuracy of colon capsule endoscopy
Date of disclosure of the study information 2014/01/27
Last modified on 2021/05/10

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Basic information
Public title Prospective study for the diagnostic accuracy of colon capsule endoscopy
Acronym colon capsule endoscopy study
Scientific Title Prospective study for the diagnostic accuracy of colon capsule endoscopy
Scientific Title:Acronym colon capsule endoscopy study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy of colon capsule endoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic accuracy of colon capsule endoscopy
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
Device,equipment
Interventions/Control_1 patient has both colon capsule endoscopy and colonoscopy.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The patiet who is suspected with colorectal disease and is going to have colonoscopy.
Key exclusion criteria 1. suspected gastrointstinal stenosis
2. know Crohn's disease
3. suspected intestinal stenosis due to radiation therapy
4. the patient who has trouble with the patency of gastrointestinal tract on post-abdominal surgery period
5. pacemaker or ICD implantation
6. known or suspected dysphagia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2172
Email hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanao Nakamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya 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
2014 Year 01 Month 27 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
2014 Year 01 Month 24 Day
Date of IRB
2014 Year 01 Month 24 Day
Anticipated trial start date
2014 Year 01 Month 27 Day
Last follow-up date
2017 Year 03 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 26 Day
Last modified on
2021 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014003

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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