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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013473
Receipt No. R000015729
Scientific Title Comparison of closure method between hemoclip and snare coaglation after endoscopic mucosal resection
Date of disclosure of the study information 2014/04/01
Last modified on 2015/04/20

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Basic information
Public title Comparison of closure method between hemoclip and snare coaglation after endoscopic mucosal resection
Acronym Closure method between hemoclip and snare coaglation
Scientific Title Comparison of closure method between hemoclip and snare coaglation after endoscopic mucosal resection
Scientific Title:Acronym Closure method between hemoclip and snare coaglation
Region
Japan

Condition
Condition Coolorectal polipoid lesion within 20 mm which is indication of EMR
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prevention methods of post EMR bleeding are as follows: 1. no treatment 2. closure using by hemoclip 3. coagration by tip of snare. Among these method, we evaluate procedure time, post EMR bleeding and cost of treatment between clip and snare coaglation group
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post EMR treatment procedure time between clip and snare coaglation group
Key secondary outcomes 1.Post EMR bleeding rate of treatment between clip and snare coaglation group
2.Treatment cost between clip and snare coaglation group

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Post EMR site closure by hemoclip
Interventions/Control_2 Post EMR coaglation by tip of snare
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Colorectal polyp within 20 mm in diameter
Key exclusion criteria Colorectal polyp over 20 mm in diameter
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University
Ehime Rousai Hospital
Division name Department of Gastroenterology and Neurology
Zip code
Address 1720-1, Miki, Kida, Kagawa ,Japan
TEL 087-891-2156
Email hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazunori Yamashita
Organization Ehime Rousai Hospital
Division name Medical Affairs Division
Zip code
Address 13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL 0897-33-6191
Homepage URL
Email ijikachou@ehimerosai.jp

Sponsor
Institute Ehime Rousai Hospital
Institute
Department

Funding Source
Organization Kagawa University
Organization
Division
Category of Funding Organization
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
2014 Year 04 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
2014 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2014 Year 03 Month 20 Day
Last modified on
2015 Year 04 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015729

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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