UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017049 |
|---|---|
| Receipt number | R000019204 |
| Scientific Title | To analyze hemodynamics of testis with varicocele and verify the conventional classification criteria of the varicocele using ultrasound contrast agents, perflubutane |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2018/04/10 08:14:12 |
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Basic information
Public title
To analyze hemodynamics of testis with varicocele and verify the conventional classification criteria of the varicocele using ultrasound contrast agents, perflubutane
Acronym
To analyze hemodynamics of testis with varicocele and verify the conventional classification criteria of the varicocele using ultrasound contrast agents
Scientific Title
To analyze hemodynamics of testis with varicocele and verify the conventional classification criteria of the varicocele using ultrasound contrast agents, perflubutane
Scientific Title:Acronym
To analyze hemodynamics of testis with varicocele and verify the conventional classification criteria of the varicocele using ultrasound contrast agents
Region
| Japan |
Condition
Condition
varicocele
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze the hemodynamics in the testis of the patient with varicocele by contrast ultrasound sonography using perflubutane (Sonazoid). From a provided result, we inspect a conventional criteria of the varicocele using B-mode and color Doppler imaging.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1:Evaluation by B-mode and color Doppler imaging
the size of the testis, the spermatic cord vein diameter, the grade of varicocele
2:Evaluation by the contrast ultrasound sonography
TTP(time to peak arterial circulation), MTT(mean transit time), artery circulation time (wash-in), venous circulation time (wash-out)
Key secondary outcomes
Base
Study type
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
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Contrast-enhanced US of the varicocele with Sonazoid
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)A patient with the varicocele on the left side
2)Written informed consent
Key exclusion criteria
1)A patient under age
2)A patient who had the operation in the past
3)A patient who have the varicocele in the right side predominance
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko Fukuda |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461
TEL
03-3433-1111
fukuda@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Watanabe |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461
TEL
03-3433-1111
Homepage URL
kwata_1015@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Department of Radiology
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019204
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| Registered date | File name |
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| Registered date | File name |
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