UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of microsurgical subinguinal varicocelectomy using indocyanine green fluorescence angiography
Title of the study (Brief title)	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	Yasuhiro Shibata
Organization	Gunma University Hospital
Division name	Urology
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	Yasuhiro Shibata
Organization	Gunma University Graduate School
Division name	Urology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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