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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035735
Receipt No. R000040709
Scientific Title Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Date of disclosure of the study information 2019/02/01
Last modified on 2019/08/09

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Basic information
Public title Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Acronym Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Scientific Title Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Scientific Title:Acronym Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Region
Japan North America

Condition
Condition Gastrointestinal bleeding
Classification by specialty
Gastroenterology Gastrointestinal surgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of novel simulation model for endoscopic hemostasis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate effectiveness of the novel simulation model for endoscopic trainee.
Key secondary outcomes To clarify factors associated with difficulty of upper gastrointestinal endoscopic hemostasis.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Investigator will take informed consent from participants by oral agreement. Then participants will complete the questionnaires both before and after simulation training. Training for endoscopic hemostasis will be provided using bleeding ulcer models attaching with antrum and body of stomach. This model has been developed by the investigators and Denka corporation. Investigator will msure time of procedure and also give appropriate technical feedback to trainee.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Gastroenterological doctor or resident doctor who is belonging to McMaster University, Tohoku University, or related hospitals of Tohoku University.
Key exclusion criteria Exclusion criteria will be the trainees who cannot speak English in Canada,and who cannot speak Japanese in Japan.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Koike
Organization Tohoku University Hospital
Division name Division of Gastroenterology
Zip code 980-8575
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575 JAPAN
TEL 022-717-7171
Email tkoike@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kanno
Organization Tohoku University graduate school of Medicine
Division name Division of Gastroenterology
Zip code 980-8575
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575 JAPAN
TEL 022-717-7171
Homepage URL
Email kanno.takeshi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Gastroenterology, McMaster University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, JAPAN
Tel +81-22-717-8007
Email med-kenkyo@grp.tohoku.ac.jp

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
2019 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 31 Day
Date of IRB
2019 Year 01 Month 28 Day
Anticipated trial start date
2019 Year 01 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040709

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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