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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025945
Receipt No. 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

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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
Email 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
Email mritobk@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029829

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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