UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013256 |
|---|---|
| Receipt number | 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 13:13:11 |
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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
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
haya_two@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013249
