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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017841
Receipt No. R000020673
Scientific Title Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Date of disclosure of the study information 2015/06/09
Last modified on 2017/12/13

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Basic information
Public title Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Acronym Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Scientific Title Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Scientific Title:Acronym Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Region
Japan

Condition
Condition varicocele
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We studied the efficacy of intra-operative indocyanine green angiography during microsurgical subinguinal varicocelectomy in a small number of patients to get preliminary data for upcoming clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Imaging of the seminal cord vessels by intra-operative ICG angiography.
Key secondary outcomes

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous injection of ICG during operation.
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) Patients of twenty years and up.
2) Patients diagnosed as varicocele.
3) Patients with abnormal semen tests as stated below or chronic scrotal pain associated with varicocele.
Volume: less than 1.5ml
Concentration: less than 15 million sperms/ml
Motility: less than 50%
4) Agreed to be involved in the study by document.
Key exclusion criteria 1) Patients with allergic reaction for anesthesia agents.
2) Patients with previous treatment history for varicocele.
3) Patients who cannot come to hospital for evaluation.
4) Patients that are decided as not suitable for the study by doctors in charge.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Shibata
Organization Gunma University Hospital
Division name Urology
Zip code
Address 3-39-15 Showa-machi Maebashi Gunma, 371-8511, Japan
TEL 027-220-8315
Email yash@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Shibata
Organization Gunma University Graduate School
Division name Urology
Zip code
Address 3-39-15 Showa-machi Maebashi Gunma, 371-8511, Japan
TEL 027-220-8303
Homepage URL
Email yash@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital Department of Urology
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 09 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 04 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 06 Month 09 Day
Last modified on
2017 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020673

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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