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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035276
Receipt No. R000024640
Scientific Title Endoscopic resection of early GI tract tumor using the Clutch Cutter
Date of disclosure of the study information 2018/12/17
Last modified on 2018/12/17

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Basic information
Public title Endoscopic resection of early GI tract tumor using the Clutch Cutter
Acronym Clinical research using the Clutch Cutter
Scientific Title Endoscopic resection of early GI tract tumor using the Clutch Cutter
Scientific Title:Acronym Clinical research using the Clutch Cutter
Region
Japan

Condition
Condition early GI tract tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of usefullness of endoscopic resection using the Clutch Cutter for ki
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes R0 resection rate
Complication rate
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
100 years-old >=
Gender Male and Female
Key inclusion criteria early GI tract tumo
Key exclusion criteria Advanced GI cancer
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Akahoshi
Organization Aso Iizuka Hospital
Division name Gastroenterology
Zip code
Address 3-83 Yoshio, Iizuka, Japan
TEL 0948-22-3800
Email kakahoshi2@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Akahoshi
Organization Aso Iizuka Hospital
Division name Gastroenterology
Zip code
Address 3-83 Yoshio, Iizuka, Japan
TEL 0948-22-3800
Homepage URL
Email kakahoshi2@aol.com

Sponsor
Institute Aso Iizuka Hospital
Institute
Department

Funding Source
Organization Aso Iizuka Hospital
Organization
Division
Category of Funding Organization Other
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
2018 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
Clinical outcome

Management information
Registered date
2018 Year 12 Month 17 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024640

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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