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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028073
Receipt No. R000032141
Scientific Title Study on the extracellular fluid status in the legs with varicose veins of various severity.
Date of disclosure of the study information 2017/07/04
Last modified on 2018/01/04

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Basic information
Public title Study on the extracellular fluid status in the legs with varicose veins of various severity.
Acronym Extracellular fluid status in legs with varicose vein.
Scientific Title Study on the extracellular fluid status in the legs with varicose veins of various severity.
Scientific Title:Acronym Extracellular fluid status in legs with varicose vein.
Region
Japan

Condition
Condition Venous disease
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To provide the objective measure in the assessment of excess extracellular fluid accumulation in legs with varicose veins.
Basic objectives2 Others
Basic objectives -Others Same as above.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bioimpedance in each clinical class of CEAP(Clinical, Anatomical, Etiological, Pathophysiological) classification.
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Bioelectorical impedance analysis.
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 and Female
Key inclusion criteria All the patients who visit Yamaguchi University Hospital because of varicose vein in the leg.
Key exclusion criteria Those whom we consider inappropriate because of physical and/or mental problems.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Surgery and Clinical Science, Division of Vascular Surgery
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2261
Email surg-1@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Suehiro
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Surgery and Clinical Science, Division of Vascular Surgery
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2261
Homepage URL
Email ksuehiro@yamaguchi-u.ac.jp

Sponsor
Institute Department of Surgery and Clinical Science, Division of Vascular Surgery
Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 07 Month 04 Day
Last modified on
2018 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032141

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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