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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013256
Receipt No. R000013249
Scientific Title Clinical Application of Non-Invasive Diagnostic Device for Aortic Aneurysms
Date of disclosure of the study information 2014/03/01
Last modified on 2019/02/05

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Basic information
Public title Clinical Application of Non-Invasive Diagnostic Device for Aortic Aneurysms
Acronym DETECT-A
Scientific Title Clinical Application of Non-Invasive Diagnostic Device for Aortic Aneurysms
Scientific Title:Acronym DETECT-A
Region
Japan

Condition
Condition Aortic aneurysm
Classification by specialty
Cardiology Vascular surgery Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Early detection of aortic aneurysms with non-invasive diagnostic device.
Basic objectives2 Others
Basic objectives -Others Evaluation of sensitivity and specificity of the device for aortic aneurysms.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Accuracy of the aortic aneurysm detection
Key secondary outcomes Change of unstable behavior area estimated with this device after aortic operation

Base
Study type Interventional

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Patients need to be evaluated for two times in their hospitalization. Pre and Post operative examination are performed, respectively.
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 All cases hospitalized in our ward for cardiovascular surgery and who takes CT or MRI for pre-operative examinations.
Key exclusion criteria Emergency case.
Patients that the informed consent can't get from.
Patients who can't keep quiet in bed.
Patients who are inadequate for this study judged by attending doctors.
Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Kawamoto
Organization Tohoku University
Division name Cardiovascular Surgery
Zip code
Address 1-1, Seiryocho, Aoba, Sendai city, Miyagi, Japan
TEL 022-717-7222
Email shunsukekawamoto@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Hayatsu
Organization Tohoku University
Division name Cardiovascular Surgery
Zip code
Address 1-1, Seiryocho, Aoba, Sendai city, Miyagi, Japan
TEL 022-717-7222
Homepage URL
Email haya_two@yahoo.co.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku 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
2014 Year 03 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 Completed
Date of protocol fixation
2013 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 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
2014 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013249

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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