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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023698
Receipt No. R000027291
Scientific Title Efficacy of String Clip Suturing Method
Date of disclosure of the study information 2016/09/01
Last modified on 2017/09/30

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Basic information
Public title Efficacy of String Clip Suturing Method
Acronym String Clip Suturing Method
Scientific Title Efficacy of String Clip Suturing Method
Scientific Title:Acronym String Clip Suturing Method
Region
Japan

Condition
Condition Duodenal adenoma or early cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The feasibility of string clip suturing method is evaluated in a clinical pilot study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate
Key secondary outcomes Procedure time,Adverse events

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 String clip suturing method
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria This study involves patients who undergo endoscopic treatment for duodenal adenoma or early cancer.
Key exclusion criteria 1. Allergy to polyester
2. Presence of clinically significant underlying renal disease
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Naohisa Yahagi
Organization Keio University School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3914
Email yahagi.keio@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Toshihiro Nishizawa
Organization Keio University School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3914
Homepage URL
Email nisizawa@kf7.so-net.ne.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
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
2016 Year 09 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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 08 Month 21 Day
Date of closure to data entry
2017 Year 08 Month 21 Day
Date trial data considered complete
2017 Year 08 Month 21 Day
Date analysis concluded
2017 Year 08 Month 21 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 20 Day
Last modified on
2017 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027291

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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