UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017835 |
|---|---|
| Receipt number | R000020664 |
| Scientific Title | The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases |
| Date of disclosure of the study information | 2015/06/08 |
| Last modified on | 2015/06/09 08:04:15 |
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Basic information
Public title
The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Acronym
ultra-small caliber SBE
Scientific Title
The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Scientific Title:Acronym
ultra-small caliber SBE
Region
| Japan |
Condition
Condition
difficult insertion cases by standard SBE
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of endoscopic insertion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Insertion improvement changing from standard SBE(SIF-Q260) to ultra-small caliber SBE(SIF-Y0006)
Key secondary outcomes
safety, insertion time and length of both SBE
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
change to SIF-Y0006 scope
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The insertion length below 1m using SIF-Q260
Key exclusion criteria
In case of the deeper insertion is considered as dageourous or not perferable
In casde of not preferable using SIF-Y0006
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Endo |
Organization
OFUNA CHUO HOSPITAL
Division name
G.I./IBD center
Zip code
Address
6-2-24 Ofuna, Kamakura, kanagawa, Japan
TEL
0467-45-2111
yutaka-endo@ofunachuohp.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Endo |
Organization
OFUNA CHUO HOSPITAL
Division name
G.I./IBD center
Zip code
Address
6-2-24 Ofuna, Kamakura, kanagawa, Japan
TEL
0467-45-2111
Homepage URL
yutaka-endo@ofunachuohp.net
Sponsor or person
Institute
GI/IBD center, Ofuna Chou hospital
Institute
Department
Personal name
Funding Source
Organization
olympus company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Endoscopy University Hospital of Medicine Tokyo Medical and Dental University
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
| 2015 | Year | 06 | Month | 08 | 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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 08 | Day |
Last modified on
| 2015 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020664
