UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The anatomical variations of lower limb lymph vessels by indocyanine green fluorescence lymphography in analysis of healthy volunteers
Title of the study (Brief title)	The anatomical variations of lower limbs lymph vessels by ICG fluorescence lymphography in analysis of healthy volunteers
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Vascular surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the anatomical variations of lower limb lymph vessels of healthy volunteers.
Basic objectives2	Others
Basic objectives -Others	We investigate the anatomical variations of lower limb lymph vessels of healthy volunteers.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	We classify the anatomical variations of lower limb lymph vessels and investigate the frequency.
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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Healthy volunteers have subcutaneous injection of 0.1ml indocyanine green (0.5%) and are investigated the anatomical variations of lower limb lymph vessels.
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	18 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy volunteers
Key exclusion criteria	Subjects with varicose veins or peripheral artery disease in the legs, medical history of lymphedema, deep vein thrombosis, radiation therapy, prescription of cancer agents, current pregnancy, iodine allergy or leg trauma are excluded.
Target sample size	150

Research contact person
Name of lead principal investigator	Naoki Unno
Organization	Hamamatsu University School of Medicine
Division name	Secondary department of surgery
Address	1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka
TEL	053-435-2279
Email	unno@hama-med.ac.jp

Public contact
Name of contact person	Takaaki Saito
Organization	Hamamatsu University School of Medicine
Division name	Secondary department of surgery
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL	053-435-2279
Homepage URL
Email	takasaito0711@gmail.com

Sponsor
Institute	Secondary department of surgery, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	浜松医科大学（静岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 29 Day
Last modified on	2018 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038215