UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029361 |
|---|---|
| Receipt number | R000033556 |
| Scientific Title | Abdominal belt for insertion of colonoscopy |
| Date of disclosure of the study information | 2017/10/14 |
| Last modified on | 2018/10/13 06:10:04 |
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Basic information
Public title
Abdominal belt for insertion of colonoscopy
Acronym
Abdominal belt for colonoscopy
Scientific Title
Abdominal belt for insertion of colonoscopy
Scientific Title:Acronym
Abdominal belt for colonoscopy
Region
| Japan |
Condition
Condition
Patients who undergo colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of adominal belt for the insertion of colonoscopy is assessed by randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insertion time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Abdominal belt
Interventions/Control_2
Control
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
1. Patients who undergo colonoscopy
2. Age; 20 years or more
3. Obesity (BMI: 25 or moe) or thinness (BMI: less than 18.5) or difficulty of colonoscopy insertion (8 minutes or more)
Key exclusion criteria
(1) presence of clinically significant underlying disease (hepatic or renal disease); (2) history of colonic surgery; (3) Ulcerative colitis (4) pregnancy or nursing; (5) allergy to latex;(6) ineligibility for trial as determined by a physician;
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Toyoshima |
Organization
TOYOSHIMA Endoscopy CLINIC
Division name
Gastroenterology
Zip code
Address
6-17-5 Seijo, Setagaya-ku, Tokyo
TEL
03-5429-9555
t@ichou.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
Organization
Tokyo Medical Center
Division name
Gastroenerology
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
nisizawa@kf7.so-net.ne.jp
Sponsor or person
Institute
Toyoshima Endoscopy Clinic
Institute
Department
Personal name
Funding Source
Organization
Toyoshima Endoscopy Clinic
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
| 2017 | Year | 10 | Month | 14 | 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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 13 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033556
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
