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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024375
Receipt No. R000028063
Scientific Title The efficacy of new bipolar hemostatic forceps for endoscopic resection
Date of disclosure of the study information 2016/10/13
Last modified on 2017/10/18

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Basic information
Public title The efficacy of new bipolar hemostatic forceps for endoscopic resection
Acronym The efficacy of new hemostatic forceps for ER
Scientific Title The efficacy of new bipolar hemostatic forceps for endoscopic resection
Scientific Title:Acronym The efficacy of new hemostatic forceps for ER
Region
Japan

Condition
Condition the gastrointestinal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficasy of new bipolar hemostatic forceps for bleeding during endoscopic resection of the GI tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the successful rate of hemostasis
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 new bipolar hamostatic forceps
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 Patient for gastrointestinal tumor and subjected to endoscopic resection.
Key exclusion criteria Patient who judged that we were inappropriate to perform examination safely.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohisa Yahagi
Organization Keio University
Division name Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3437
Email yahagi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutoshi Ochiai
Organization Keio University
Division name Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3437
Homepage URL
Email yochiai.a7@keio.jp

Sponsor
Institute Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Institute
Department

Funding Source
Organization Center for Research and Development of Minimally Invasive Treatment, Cancer Center, 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 10 Month 13 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 07 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 13 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
2016 Year 10 Month 12 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028063

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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