UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011309 |
|---|---|
| Receipt number | R000013253 |
| Scientific Title | Clinical applications of non invasive Doppler ultrasound urodynamic study |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2017/02/01 23:20:10 |
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Basic information
Public title
Clinical applications of non invasive Doppler ultrasound urodynamic study
Acronym
Doppler ultrasound urodynamic study
Scientific Title
Clinical applications of non invasive Doppler ultrasound urodynamic study
Scientific Title:Acronym
Doppler ultrasound urodynamic study
Region
| Japan |
Condition
Condition
Benign prostatic hypertrophy
Neurogenic bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess reliability of evaluation for lower urinary tract function using Doppler ultrasound urodynamic study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of cases who can be measured velocity related parameters against total number of cases studied.
Key secondary outcomes
Functional cross sectional area at prostatic urethra (A1)
Velocity ratio (VR: Velocity above the sphincter divided by that below it)
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound probe positioning using a remote controlled robotic manipultor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Agreement of the patient
Key exclusion criteria
Patients who cannot void on the ultrasound probe at the perineal region.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Ozawa |
Organization
Mizushima Central Hospital
Division name
Department of Urology
Zip code
Address
4-5 Mizushima-aoba chou, Kurashiki, Okayama
TEL
086-444-3311
UrOzawa@aol.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Ozawa |
Organization
Mizushima Central Hospital
Division name
Department of Urology
Zip code
Address
4-5 Mizushima-aoba chou, Kurashiki, Okayama
TEL
81864443311
Homepage URL
UrOzawa@aol.jp
Sponsor or person
Institute
Kawasaki Medical School General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Hospital, Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
1509
Org. issuing International ID_1
Kawasaki Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
川崎医科大学川崎総合医療センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 29 | Day |
Last modified on
| 2017 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013253
