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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025897
Receipt No. R000029775
Scientific Title Efficacy of narrow and ball tipped knife with water jet function for colorectal endoscopic submucosal dissection
Date of disclosure of the study information 2017/02/01
Last modified on 2018/09/05

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Basic information
Public title Efficacy of narrow and ball tipped knife with water jet function for colorectal endoscopic submucosal dissection
Acronym Efficacy of narrow knife for colorectal ESD
Scientific Title Efficacy of narrow and ball tipped knife with water jet function for colorectal endoscopic submucosal dissection
Scientific Title:Acronym Efficacy of narrow knife for colorectal ESD
Region
Japan

Condition
Condition Colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the efficacy of narrow knife for colorectal ESD with respect to vacuum function, water jet function, and knife insertion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of vacuum function in basic and clinical research
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases with adenoma and early cancer 20-50mm in size
Key exclusion criteria Cases with serious dysfunction of main organs
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Email naohisa@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Homepage URL
Email naohisa@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kobe University Hospital
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 京都府立医科大学附属病院(京都府)、神戸大学医学部附属病院(兵庫県)

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 Completed
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 01 Month 30 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 02 Month 01 Day

Other
Other related information To analyze the efficacy of narrow knife for colorectal ESD with respect to vacuum function, water jet function, and knife insertion.

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029775

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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