UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013856 |
|---|---|
| Receipt number | R000016161 |
| Scientific Title | Effectiveness of prophylactic clip for preventing delayed bleeding on endoscopic resection of colon polyp |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/09/03 19:54:26 |
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Basic information
Public title
Effectiveness of prophylactic clip for preventing delayed bleeding on endoscopic resection of colon polyp
Acronym
clip
Scientific Title
Effectiveness of prophylactic clip for preventing delayed bleeding on endoscopic resection of colon polyp
Scientific Title:Acronym
clip
Region
| Japan |
Condition
Condition
colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
effectiveness of prophylactic clip
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
preventing delayed bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
clip
Interventions/Control_2
none clip
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
heart failure
kidney failure
infection
diabetes
poor nutrition
blood disease
mental disorder
other critical disease
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kogo |
Organization
asahikawa medical university
Division name
division of gastroenterology and hematology oncology
Zip code
Address
midorigaoka higasi 2jo1tyome 1-1 asahikawa city hokkaido
TEL
0166-68-2462
ta1983@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Dokoshi |
Organization
asahikawa medical university
Division name
division of gastroenterology and hematology oncology
Zip code
Address
midorigaoka higasi 2jo1tyome 1-1 asahikawa city hokkaido
TEL
0166-68-2462
Homepage URL
ta1983@asahikawa-med.ac.jp
Sponsor or person
Institute
division of gastroenterology and hematology oncology
Institute
Department
Personal name
Funding Source
Organization
division of gastroenterology and hematology oncology
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
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 01 | Day |
Last modified on
| 2014 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016161
