UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013473 |
|---|---|
| Receipt number | 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 19:36:02 |
* 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
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
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
ijikachou@ehimerosai.jp
Sponsor or person
Institute
Ehime Rousai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015729
