UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034979 |
|---|---|
| Receipt number | R000039595 |
| Scientific Title | A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy |
| Date of disclosure of the study information | 2018/11/25 |
| Last modified on | 2019/05/24 10:30:01 |
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Basic information
Public title
A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy
Acronym
Effectiveness of saline injection of cold snare polypectomy
Scientific Title
A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy
Scientific Title:Acronym
Effectiveness of saline injection of cold snare polypectomy
Region
| Japan |
Condition
Condition
colon polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Histological analysis of the specimens resected by conventional cold snare polypectomy or cold snare polypectomy using saline injection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Histological analysis of resected specimens
Key secondary outcomes
The incidence of delayed bleeding
The incidence of delayed perforation
The incidence of immediate bleeding
Other adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional cold polypectomy
Interventions/Control_2
Cold polypectomy with saline injection
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) 20 years old and older
2) Polyps less than 10 mm in diameter
3) Written informed consent
Key exclusion criteria
1) Polyps suspected of being cancers
2) Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology
Zip code
6028566
Address
Kajii-cho465, Kamigyo-ku, Kyoto
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Harusato |
Organization
Kyoto Prefectural University of Medicine
Division name
North Medical Center, Department of Gastroenterology
Zip code
6292261
Address
Otokoyama 481, Yosano, Kyoto, Japan
TEL
0772-46-3371
Homepage URL
harup@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuchiyama City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kajii-cho 465, Kamigyo-ku, Kyoto city
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
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
京都府立医科大学及び附属北部医療センター、市立福知山市民病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039595
