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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010547
Receipt No. R000012333
Scientific Title A prospective study under endoscopic treatment which examines the convenient propofol use
Date of disclosure of the study information 2013/04/19
Last modified on 2014/04/21

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Basic information
Public title A prospective study under endoscopic treatment which examines the convenient propofol use
Acronym A prospective study under endoscopic treatment which examines the convenient propofol use
Scientific Title A prospective study under endoscopic treatment which examines the convenient propofol use
Scientific Title:Acronym A prospective study under endoscopic treatment which examines the convenient propofol use
Region
Japan

Condition
Condition The patient who owns the digestive diseases diagnosed as passing and the endoscopic treatment under vein general anesthesia being requirement
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The endoscopic treatment in the deep sedation validates simple sedation by the propofol of minimum quantity in the bottom general anesthesias of vein in the patient which is adapted.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes validity by propofol use by this medication method
Key secondary outcomes evaluation of dose by the background factor difference of patient with the use of propofol

Base
Study type

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
Medicine
Interventions/Control_1 Treatment will set in necessary 50 cases endoscopically by December 31, 2016 from the ethics committee approved the study. It is kept calm, increasing from the amount of 1 ml/h for 4 minutes of weight at a very small amount for lowest available doses (1 ml for 20 minutes of weight), and maintenance for use of propofol are needed on an attachment 1% at the time of induction of anesthesia 10 seconds.
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 The patient who owns the digestive diseases diagnosed as passing and the endoscopic treatment under vein general anesthesia being requirement
Key exclusion criteria 1) The example of Informed Consent (IC) refusal.2) The direction which has merged critical liver disease, cardiac disease, a respiratory ailment, etc., and is considered that operative endoscopy is difficult.3)patient who haveallergy to eggs.4)patient who have unknown or serious allergic constitution.
4)the patient whom the doctor specializing in an exam judged to be unfit as focus of our study


Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kenshi matsumoto
Organization Juntendo university
Division name gastroenterology
Zip code
Address 2-1-1 hongo bunkyo-ku Tokyo
TEL 03-3813-8111
Email kmatumo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kenshi matsumoto
Organization juntendo university
Division name gastroenterology
Zip code
Address 2-1-1 hongo bunkyo-ku Tokyo
TEL 03-3813-3111
Homepage URL http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
Email kmatumo@juntendo.ac.jp

Sponsor
Institute Juntendo university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 順天堂大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 19 Day

Related information
URL releasing protocol http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
Publication of results Unpublished

Result
URL related to results and publications http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 16 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 06 Month 01 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 19 Day
Last modified on
2014 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012333

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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