UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032155 |
|---|---|
| Receipt number | R000036683 |
| Scientific Title | Utility of measuring intravesical urine volume at the perioperative period and validation of accuracy of Lilium alpha-200 for ultrasonic diagnostic imaging system for bladder |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2019/12/25 18:59:19 |
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Basic information
Public title
Utility of measuring intravesical urine volume at the perioperative period and validation of accuracy of Lilium alpha-200 for ultrasonic diagnostic imaging system for bladder
Acronym
Utility and Accuracy of measuring intravesical urine volume at the perioperative period with Lilium alpha-200
Scientific Title
Utility of measuring intravesical urine volume at the perioperative period and validation of accuracy of Lilium alpha-200 for ultrasonic diagnostic imaging system for bladder
Scientific Title:Acronym
Utility and Accuracy of measuring intravesical urine volume at the perioperative period with Lilium alpha-200
Region
| Japan |
Condition
Condition
Knee surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to measure intravesical urine volume with Lilium alpha-200 and study its validation and accuracy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urine volume, Intravesical unine volume and residual urine volume measured with Lilium alpha-200 during operation
Key secondary outcomes
infusion amount
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 and Female
Key inclusion criteria
elective knee suregery
Key exclusion criteria
Patients who have active cystisis
History of surgery of urinary bladder
Surgical scar at lower abdomen
Patients on hemodialysis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Suzuki |
Organization
Tokai University School of Medicine
Division name
Anesthesiology
Zip code
2591193
Address
Shimokasuya 143, Isehara city, Kanagawa, Japan
TEL
0463-93-1121
genya@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Genya |
| Middle name | |
| Last name | Urimoto |
Organization
Tokai University School of Medicine
Division name
Anesthesiology
Zip code
2591193
Address
143 Shimokasuya, Isehara city, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
genya@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine, self funding
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
Tokai University School of Medicine
Address
143 Shimokasuya, Isehara city, Kanagawa, Japan
Tel
0463-93-1121
genya@is.icc.u-tokai.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 | 04 | Month | 09 | 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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
We measure volume of urinary bladder with Lilium alpha-200. Urinary catheter is clamped for 30-60minutes and when it is de-clamped, measure the amount of urine and compare it with (Urinary bladder volume before the catheter is de-clamped)-(Urinary bladder volume after the catheter is de-clamped). We compare both values with Bland-Altman plot to test its accuracy.
Management information
Registered date
| 2018 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036683
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
