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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036901
Receipt No. R000042028
Scientific Title Difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/30

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Basic information
Public title Difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Acronym Difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Scientific Title Difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Scientific Title:Acronym Difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Region
Japan

Condition
Condition colorectal adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the difference of complete resection of cold snare polypectomy between thin wire type and normal wire snares for small colorectal polyps
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histological complete resection rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 GroupA
We perform cold snare polypectomu using normal type snare.
Interventions/Control_2 GroupB
We perform cold snare polypectomu using thin type snare.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients whose performance state is 0,1,2(ECOG).
2)Patients whose lesion was diagnosed less than 10mm in diameter and protruded morphology without pedunculated type.
3)Patients who provided written informed consent.
Key exclusion criteria 1)Patients who can not take pre-treatment drug for colonoscopy.
2)patients who is allergic to a pre-treatment drug or sedative drug.
3)Pregnant patient.
4)Breast-feeding patients
5)Patients with a diagnosis of FAP and patients with a family history.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Sho
Middle name
Last name Suzuki
Organization Nihon university hospital
Division name Department of Gastroenterology
Zip code 101-8309
Address 1-6,KANDA-SURUGADAI CHIYODA-KU,TOKYO
TEL 03-3293-1711
Email s.sho.salubriter.mail@gmail.com

Public contact
Name of contact person
1st name Toshiki
Middle name
Last name Horii
Organization Yuri-Kumiai General Hospital
Division name Department of Gastroenterology
Zip code 015-8511
Address 38,KAWAGUCHI-YAGO,YURIHONJO-SHI,AKITA
TEL 0184-27-1200
Homepage URL
Email horiitoshiki@gmail.com

Sponsor
Institute Yuri-Kumiai General Hospital
Institute
Department

Funding Source
Organization none
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 Yuri-Kumiai General Hospital
Address 38,KAWAGUCHI-YAGO,YURIHONJO-SHI,AKITA
Tel 0184-27-1200
Email soumukanri@yuri-hospital.honjo.akita.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 15 Day
Date of IRB
2019 Year 05 Month 28 Day
Anticipated trial start date
2019 Year 05 Month 30 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
2020 Year 06 Month 15 Day
Date trial data considered complete
2020 Year 06 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 30 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042028

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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