UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036683