UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017841 |
|---|---|
| Receipt number | 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 18:07:40 |
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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
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
yash@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020673
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
