UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030345 |
|---|---|
| Receipt number | R000034653 |
| Scientific Title | Investigation on measurement accuracy of Lilium a- 200, a bladder volume ultrasound imaging device (preliminary study). |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/09/06 13:23:33 |
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Basic information
Public title
Investigation on measurement accuracy of Lilium a- 200, a bladder volume ultrasound imaging device (preliminary study).
Acronym
LLM-001
Scientific Title
Investigation on measurement accuracy of Lilium a- 200, a bladder volume ultrasound imaging device (preliminary study).
Scientific Title:Acronym
LLM-001
Region
| Japan |
Condition
Condition
Bladder functional assessment for healthy volunteers.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the measurement accuracy of Lilium a- 200, a bladder volume ultrasound imaging device.
Basic objectives2
Others
Basic objectives -Others
To investigate accuracy and usability Evaluation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measured value by Lilium a- 200 of residual in the bladder.
Key secondary outcomes
Convenience and ease of Lilium a- 200.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To infuse by catheter saline water into the bladder.
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
Key inclusion criteria
(1)Healthy males older than 20 years,
(2)Those whose residual are less than 50 ml measured by an ultrasound imaging system (Model SSA-550A from Toshiba Medical, called "Echo").
Key exclusion criteria
(1)Those who have LUTS,
(2)Those whose residual were judged more than 50 ml by Echo.
(3)Those the chief investigator considered to be ineligible for the investigation.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mr. Shinya Sasatani |
Organization
Lilium Otsuka Co.,Ltd.
Division name
Director
Zip code
Address
4-12-6,Chiyoda,Chuo-ku,Sagamihara city Kanagawa 252-0237
TEL
042-704-3822
ssasatani@liotsuka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mr. Isao Shirasaki |
Organization
Lilium Otsuka Co.,Ltd.
Division name
President and Representative Director
Zip code
Address
4-12-6,Chiyoda,Chuo-ku,Sagamihara city Kanagawa 252-0237
TEL
042-704-3822
Homepage URL
ishirasaki@liotsuka.com
Sponsor or person
Institute
Lilium Otsuka Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lilium Otsuka Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
医療法人社団 翔医会 小金井橋さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2018 | 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=R000034653
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
