UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023875 |
|---|---|
| Receipt number | R000027503 |
| Scientific Title | A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2024/09/06 14:24:07 |
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Basic information
Public title
A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Acronym
A development of less invasive dynamic imaging inspection
Scientific Title
A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Scientific Title:Acronym
A development of less invasive dynamic imaging inspection
Region
| Japan |
Condition
Condition
respiratory disorder, pulmonary arteriopathy and aortic disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
development of less invasive dynamic imaging inspection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
a diameter of pulmonary artery and Aorta, length of rib cage
Key secondary outcomes
clinical usefulness
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
X-ray apparatus
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The Patient could get the erect position,
Key exclusion criteria
pregnant woman
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | AKINAGA |
| Middle name | |
| Last name | SONODA |
Organization
Shiga University of Medical Science
Division name
Radiology,
Zip code
5202192
Address
seta tsukinowacho, Otsu, Shiga
TEL
810775482288
akinaga@bells.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | AKINAGA |
| Middle name | |
| Last name | SONODA |
Organization
Shiga Uniceristy of Medical Science
Division name
Radiology
Zip code
5292192
Address
seta tsukinowacho, Otsu, Shiga
TEL
810775482288
Homepage URL
akinaga@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga Uniceristy of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga university of medical science
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
Shiga University of Medical Science
Address
Setastukinowacho, Otsu, Shiga
Tel
+81775483576
hqrec@belle.shiga-med.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
| 2018 | Year | 03 | Month | 31 | 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
| Delay expected |
Results Delay Reason
Due to the outbreak of COVID-19 patients, a study for research purposes in our hospitals has been restricted.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027503
