UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008212 |
|---|---|
| Receipt number | R000009680 |
| Scientific Title | A prospectiverandomized study on the efficacy of a newly developed enteroscope equipped with passive bending and high force transmission insertion tube compared with a conventional colonoscopy. |
| Date of disclosure of the study information | 2012/06/21 |
| Last modified on | 2013/12/19 13:50:02 |
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Basic information
Public title
A prospectiverandomized study on the efficacy of a newly developed enteroscope equipped with passive bending and high force transmission insertion tube compared with a conventional colonoscopy.
Acronym
A prospectiverandomized study on the efficacy of a newly developed enteroscope equipped with passive bending and high force transmission insertion tube compared with a conventional colonoscopy.
Scientific Title
A prospectiverandomized study on the efficacy of a newly developed enteroscope equipped with passive bending and high force transmission insertion tube compared with a conventional colonoscopy.
Scientific Title:Acronym
A prospectiverandomized study on the efficacy of a newly developed enteroscope equipped with passive bending and high force transmission insertion tube compared with a conventional colonoscopy.
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of newly developed enteroscope equipped with passive bending and high force transmission insertion tube
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Cecal intubation rate
Key secondary outcomes
Intubation time to cecal
Patient pain
Frequency of sedatives
Complication rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional colonoscope
Interventions/Control_2
newly developed enteroscopy equipped with passive bending and high force transmission insertion tube
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
Patients more than 20 years old, required investigation by colonoscopy
Key exclusion criteria
1 Patients with prior colectomy
2 Patients with severe inflammation
3 Patients with colon stenosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kashiwagi |
Organization
Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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 | 06 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009680
