UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033553 |
|---|---|
| Receipt number | R000038215 |
| Scientific Title | The anatomical variations of lower limb lymph vessels by indocyanine green fluorescence lymphography in analysis of healthy volunteers |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/07/29 15:24:05 |
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Basic information
Public title
The anatomical variations of lower limb lymph vessels by indocyanine green fluorescence lymphography in analysis of healthy volunteers
Acronym
The anatomical variations of lower limbs lymph vessels by ICG fluorescence lymphography in analysis of healthy volunteers
Scientific Title
The anatomical variations of lower limb lymph vessels by indocyanine green fluorescence lymphography in analysis of healthy volunteers
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Naoki Unno |
Organization
Hamamatsu University School of Medicine
Division name
Secondary department of surgery
Zip code
Address
1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka
TEL
053-435-2279
unno@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Saito |
Organization
Hamamatsu University School of Medicine
Division name
Secondary department of surgery
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2279
Homepage URL
takasaito0711@gmail.com
Sponsor or person
Institute
Secondary department of surgery, Hamamatsu University School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038215
