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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017049
Receipt No. 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

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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
Email 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
Email kwata_1015@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Department of Radiology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019204

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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