UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025945 |
|---|---|
| Receipt number | R000029829 |
| Scientific Title | Study of the specimens retrieval method resected by cold snare polypectomy |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/09/01 21:47:50 |
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Basic information
Public title
Study of the specimens retrieval method resected by cold snare polypectomy
Acronym
Retrieval method of CSP
Scientific Title
Study of the specimens retrieval method resected by cold snare polypectomy
Scientific Title:Acronym
Retrieval method of CSP
Region
| Japan |
Condition
Condition
corolectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of retrival method for specimens resected by CSP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of specimen damage rate due to suction
Key secondary outcomes
Assessment of histopathological findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
At the time of retriving specimens, detach a suction button from endoscope
Interventions/Control_2
At the time of retriving specimens, attach a suction button from endoscope
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
Polyps < 10mm
Sessile, semi-pedunculated, or 0-IIa
Key exclusion criteria
Polyps >= 10mm
Pregnancy
Patients severe comorbidity
Inflamatory bowel diseases
Polyposis
Others
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Ito |
Organization
Shinshu University School of Medicne
Division name
Gastroenterology
Zip code
Address
3-1-1 Asahi, Mastsumoto, Nagano
TEL
0263-37-2634
mritobk@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Ito |
Organization
Shinshu University School of Medicine
Division name
Gastroenterology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2634
Homepage URL
mritobk@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029829
