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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012066
Receipt No. R000014106
Scientific Title The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users
Date of disclosure of the study information 2013/10/18
Last modified on 2013/10/18

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Basic information
Public title The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users
Acronym O-GUTS clinical study of antithrombotic drugs
Scientific Title The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users
Scientific Title:Acronym O-GUTS clinical study of antithrombotic drugs
Region
Japan

Condition
Condition The case of endoscopic forceps biopsy or endoscopic treatment in patients taking antithrombotic drugs
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of the guideline for endoscopic procedures in antithrombotic drug-users from Japan Gastroenterological Endoscopy Society on July 2012
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of bleeding after endoscopic forceps biopsy or endoscopic treatment
Key secondary outcomes 1)The incidence of thromboembolic events
2)The incidence of complications except for bleeding

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who were given a written informed consent
2)Patients who take antithrombotic drugs and need endoscopic forceps biopsy or endoscopic treatment
Key exclusion criteria Patients who were disqualified for the study by their physiciens
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-1, 2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL 086-235-7219
Email hiro@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Kono, Minoru Matsubara
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL 086-235-7219
Homepage URL
Email hxnwq178@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology, Okayama University Hospital
Institute
Department

Funding Source
Organization None
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
2013 Year 10 Month 18 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
2013 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observance rate of the guideline

Management information
Registered date
2013 Year 10 Month 18 Day
Last modified on
2013 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=R000014106

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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