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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032155
Receipt No. 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 2019/04/10

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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
Email 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
Email genya@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine, Anesthesiology
Institute
Department

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
Email 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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

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 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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