UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012678 |
|---|---|
| Receipt number | R000014750 |
| Scientific Title | Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer which is detected by colonoscopy |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2016/06/24 16:32:18 |
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Basic information
Public title
Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer which is detected by colonoscopy
Acronym
Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer
Scientific Title
Efficacy of capsule endoscopy on the diagnosis of advanced colorectal cancer which is detected by colonoscopy
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
yamada-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
yamada-a@umin.ac.jp
Sponsor or person
Institute
Department of Gastroentelorogy, University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014750
