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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011875
Receipt No. R000013879
Scientific Title Pressure of intra-lymphatic vessels,intravenous and subcutaneous in patients with lymphedema.
Date of disclosure of the study information 2013/10/01
Last modified on 2020/01/21

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Basic information
Public title Pressure of intra-lymphatic vessels,intravenous and subcutaneous in patients with lymphedema.
Acronym Pressure of intra-lymphatic vessels,intravenous and subcutaneous in patients with lymphedema.
Scientific Title Pressure of intra-lymphatic vessels,intravenous and subcutaneous in patients with lymphedema.
Scientific Title:Acronym Pressure of intra-lymphatic vessels,intravenous and subcutaneous in patients with lymphedema.
Region
Japan

Condition
Condition lymphedema
Classification by specialty
Vascular surgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 clarify the relationship between severity of lymphedema and pressure of intra-lymphatic vessels, intravenous and subcutaneous.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between severity of lymphedema and pressure of intra-lymphatic vessels, intravenous and subcutaneous.
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 Mesurement pressure of intra-lymphatic vessels, intravenous,and subcutaneous.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria patient with lymphedema who wish surgical treatment.
Key exclusion criteria edema not caused by lymphedema.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maegawa Jiro
Organization Yokohama city University
Division name Plastic and Reconstructive Surgery
Zip code
Address 3-9 hukuura, kanazawa-ku, yokohama city 236-0004
TEL 045-787-2800
Email maegawaj@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maegawa Jiro
Organization Yokohama city University
Division name Plastic and Reconstructive Surgery
Zip code
Address 3-9 hukuura, kanazawa-ku, yokohama city 236-0004
TEL 045-787-2800
Homepage URL
Email maegawaj@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama city University
Institute
Department

Funding Source
Organization Yokohama city University
Organization
Division
Category of Funding Organization Other
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
2013 Year 10 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
2013 Year 10 Month 01 Day
Date of IRB
2013 Year 09 Month 06 Day
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 26 Day
Last modified on
2020 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013879

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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