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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046204
Receipt No. R000052730
Scientific Title Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/26

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Basic information
Public title Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Acronym Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Scientific Title Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Scientific Title:Acronym Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Region
Japan

Condition
Condition Sessile serrated lesion
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing the safety and efficacy of CSP for the treatment of SSLs larger than 10 mm performed by both expert and non-expert
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complete resection rate, en bloc resection rate, adverse event rate, and procedure time
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 Cold snare polypectomy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with 10mm or more SSL
Key exclusion criteria Lesions with the following endoscopic findings associated with cytological dysplasia or cancer
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Kimoto
Middle name
Last name Yoshiaki
Organization NTT Medical Center Tokyo
Division name Division of Gastrointestinal Endoscopy
Zip code 141-8625
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 03-3448-6111
Email kimoto.yoshiaki@gmail.com

Public contact
Name of contact person
1st name Kimoto
Middle name
Last name Yoshiaki
Organization NTT Medical Center Tokyo
Division name Division of Gastrointestinal Endoscopy
Zip code 141-8625
Address 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL 03-3448-6111
Homepage URL
Email kimoto.yoshiaki@gmail.com

Sponsor
Institute NTT Medical Center Tokyo
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 NTT Medical Center Tokyo
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
Tel 03-3448-6111
Email kimoto.yoshiaki@gmail.com

Secondary IDs
Secondary IDs YES
Study ID_1 No. 18-81
Org. issuing International ID_1 NTT Medical Center Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 26 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 13 Day
Date of IRB
2018 Year 11 Month 13 Day
Anticipated trial start date
2018 Year 11 Month 13 Day
Last follow-up date
2028 Year 11 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052730

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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