UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007469 |
|---|---|
| Receipt number | R000008733 |
| Scientific Title | A prospective randomized study on the effficacy of a colonoscope with passive bending function |
| Date of disclosure of the study information | 2012/03/12 |
| Last modified on | 2012/03/08 11:48:13 |
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Basic information
Public title
A prospective randomized study on the effficacy of a colonoscope with passive bending function
Acronym
A prospective randomized study on a colonoscope with passive bending function
Scientific Title
A prospective randomized study on the effficacy of a colonoscope with passive bending function
Scientific Title:Acronym
A prospective randomized study on a colonoscope with passive bending function
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of a colonoscope with passive bending function, comparing with a standard colonoscope: an analysis using magnetic endoscope imaging (MEI)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient pain
Key secondary outcomes
Cecal intubation rate
Cecal intubation time
Rate of looping
Complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Colonoscope with passive bendig function(PCF-Y0005L/I, Olympus, Tokyo, Japan)
and magnetic endoscopic imagining
Interventions/Control_2
Standard colonoscope(CF260AI, Olympus, Tokyo, Japan)
and magnetic endoscopic imagining
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Age of more than 20 or less than 80 years old
2, Patients to recieve colonoscopy
3, Patients who have agreement to our
study
Key exclusion criteria
1,Those patients who are not able to
understand written information.
2, Patients with prior colectomy
3, Patients with immflammatory bowel
diseade
4, Patients with acute hemorrhagic
colitis
5, Pregnancy
6, Patients with pacemaker
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Sato |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Sato |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL
03-3468-1251
Homepage URL
kou08@oha.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
Management information
Registered date
| 2012 | Year | 03 | Month | 08 | Day |
Last modified on
| 2012 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008733
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
