UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039983 |
|---|---|
| Receipt number | R000045569 |
| Scientific Title | Evaluation of normal urinary function and pathology of lower urinary tract disorder using upright Computed Tomography |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2020/08/21 18:11:48 |
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Basic information
Public title
Evaluation of normal urinary function and pathology of lower urinary tract disorder using upright Computed Tomography
Acronym
Evaluation of urinary function using upright CT
Scientific Title
Evaluation of normal urinary function and pathology of lower urinary tract disorder using upright Computed Tomography
Scientific Title:Acronym
Evaluation of urinary function using upright CT
Region
| Japan |
Condition
Condition
normal volunteer and lower urinary tract disorder
Classification by specialty
| Urology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate urinary function in normal volunteer using upright CT.
To clarify pathology of lower urinary tract disorder using upright CT.
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical usefulness of upright CT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological parameters on images
Key secondary outcomes
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
Upright CT in a standing or sitting
positions
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy volunteers, aged from 30 to 89, who understand the
purpose of this study
2. Patients with lower urinary tract symptom, aged from 30 to 89, who understand the
purpose of this study
Key exclusion criteria
1. Subjects who do not provide written informed consent
2. Known or possible pregnancy
3. Those who have or had asthema
4. Those who have a side effect history of iodine contrast agent
5. Subjects with impaired renal function
6. Subjects who are not able to undergo upright CT
7. Claustrophobia
8. Subjects with symptoms of some kinds of disease
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1977(+81-3-3353-1977)
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-3808(+81-3-3353-3808)
Homepage URL
urotanaka@a2.keio.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports,
Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503(+81-3-5363-3503)
med-rinri-jimu@adst.keio.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
| 2020 | Year | 03 | Month | 30 | 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
| 2020 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045569
