UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007851 |
|---|---|
| Receipt number | R000009251 |
| Scientific Title | Randomized Controlled Trial to Compare the Insertability between Conventional Single Balloon Enteroscope versus Newly Developed Single Balloon Enteroscpe equipped with Passive Bending and High Force Transmission Insertion Tube. |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2013/06/15 15:41:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized Controlled Trial to Compare the Insertability between Conventional Single Balloon Enteroscope versus Newly Developed Single Balloon Enteroscpe equipped with Passive Bending and High Force Transmission Insertion Tube.
Acronym
Randomized Controlled Trial to Compare the Insertability between Conventional Single Balloon Enteroscope versus Newly Developed Single Balloon Enteroscpe equipped with Passive Bending and High Force Transmission Insertion Tube.
Scientific Title
Randomized Controlled Trial to Compare the Insertability between Conventional Single Balloon Enteroscope versus Newly Developed Single Balloon Enteroscpe equipped with Passive Bending and High Force Transmission Insertion Tube.
Scientific Title:Acronym
Randomized Controlled Trial to Compare the Insertability between Conventional Single Balloon Enteroscope versus Newly Developed Single Balloon Enteroscpe equipped with Passive Bending and High Force Transmission Insertion Tube.
Region
| Japan |
Condition
Condition
Small intestinal abmormalities
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the insertability between conventional single balloon enteroscope versus newly developed single balloon enteroscpe equipped with passive bending and high force transmission insertion tube.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Passing time from cecal valve to the terminal ileum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional Single Balloon Enteroscope
Interventions/Control_2
Newly Developed Single Balloon Enteroscpe 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 required investigation by using retrograde enteroscope.
Key exclusion criteria
1)Post ileocecal resection.
2)Cecal valve Stenosis.
3)Severe inflammation in ileocecal area.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe, M.D., Ph.D |
Organization
Keio University
Division name
Center for Diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University
Division name
Center for Diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Keio University
Digestive Disease Center, Showa University Northern Yokohama Hospital.
Division of Gastroenterology, Showa University Fujigaoka Hospital.
Institute
Department
Personal name
Funding Source
Organization
Keio University, Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Digestive Disease Center, Showa University Northern Yokohama Hospital.
Division of Gastroenterology, Showa University Fujigaoka Hospital
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
昭和大学横浜市北部病院消化器センター
昭和大学藤が丘病院消化器内科
慶應義塾大学病院内視鏡センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2013 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009251
