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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029361
Receipt No. 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

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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
Email 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
Email nisizawa@kf7.so-net.ne.jp

Sponsor
Institute Toyoshima Endoscopy Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033556

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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