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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017229
Receipt No. R000019982
Scientific Title Effectiveness of the precut coagulation at super-low output discharging set
Date of disclosure of the study information 2015/04/21
Last modified on 2016/10/28

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Basic information
Public title Effectiveness of the precut coagulation at super-low output discharging set
Acronym Effectiveness of the precut coagulation at super-low output discharging set
Scientific Title Effectiveness of the precut coagulation at super-low output discharging set
Scientific Title:Acronym Effectiveness of the precut coagulation at super-low output discharging set
Region
Japan

Condition
Condition superficial gastric tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating effectiveness of precut coagulation by Flush knife BT at super-low output discharge set
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the frequency of intraoperative hemostasis requiring hemostatic forceps
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 precut coagulation by hemostatic forceps
Interventions/Control_2 precut coagulation by Flush knife BT at super-low output discharge set
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
95 years-old >=
Gender Male and Female
Key inclusion criteria expanded criteria for gastric ESD
Key exclusion criteria Patients who
1) under antithrombotic therapy
2) have recurrence lesion
3) past radiation
4) have pregnancy
5) have infectious diseases
6) have allergy to drugs for intervention
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Horikawa
Organization Hiraka General Hospital
Division name Gastroenterology
Zip code
Address Maego, Yatsukuchi, 3-1, Yokote city
TEL 0182-32-5121
Email horikawa_01@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Horikawa
Organization Hiraka General Hospital
Division name Gastroenterology
Zip code
Address Maego, Yatsukuchi, 3-1, Yokote city
TEL 0182-32-5121
Homepage URL
Email horikawa_01@me.com

Sponsor
Institute Hiraka General Hospital
Institute
Department

Funding Source
Organization None
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
2015 Year 04 Month 21 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
2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019982

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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