UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036030 |
|---|---|
| Receipt number | R000041041 |
| Scientific Title | Evaluation of usefulness of suction marking method for colonoscopy |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2021/03/05 12:56:11 |
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Basic information
Public title
Evaluation of usefulness of suction marking method for colonoscopy
Acronym
SUCTION MARKING STUDY
Scientific Title
Evaluation of usefulness of suction marking method for colonoscopy
Scientific Title:Acronym
SUCTION MARKING STUDY
Region
| Japan |
Condition
Condition
colon tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verify whether colon suction marking when inserting colonoscope is useful for identification and rediscovery of lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discovery rate of marked polyps
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Suction marking is performed near the polyp found at the time of inserting endoscopy.
Interventions/Control_2
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
Lesion of 10 mm or less
1) flat type colon tumor (Including SSA / P)
2) Hyperplastic polyps of 6 mm or more
Key exclusion criteria
Colorectal surgery history
IBD, FAP, HNPCC
Taking anticoagulant, antiplatelet drug
Coagulation abnormality disease
During pregnancy, breast-feeding, possibility of pregnancy
doctors judge inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tomomasa tochio |
Organization
sano hospital
Division name
Gastrointestinal Center,
Zip code
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo Prefecture, Japan
TEL
0787851000
toto306052@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yasushi sano |
Organization
sano hospital
Division name
Gastrointestinal Center,
Zip code
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo Prefecture, Japan
TEL
0787851000
Homepage URL
ys_endoscopy@hotmail.com
Sponsor or person
Institute
sano hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
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
| 2019 | Year | 03 | 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
| 2018 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041041
