UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004808 |
|---|---|
| Receipt number | R000005725 |
| Scientific Title | A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases |
| Date of disclosure of the study information | 2010/12/30 |
| Last modified on | 2010/12/30 14:20:38 |
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Basic information
Public title
A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases
Acronym
Measurement of lymphatic pumping pressure in human extremities.
Scientific Title
A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases
Scientific Title:Acronym
Measurement of lymphatic pumping pressure in human extremities.
Region
| Japan |
Condition
Condition
healthy volunteers, patients with lymph edema and patients with varisou diseases
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of aging, life style, and lymph edema on human lymphatic pumping in extremities.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymph pumping pressure in extremities.
Assessment of quality of life with SF-36
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
volunteers
Key exclusion criteria
iodine allergy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Unno |
Organization
Hamamatsu University School of Medicine
Division name
Division of Vascular Surgery, Second Department of Surgery
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2279
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Unno |
Organization
Hamamatsu University School of Medicine
Division name
Division of Vascular Surgery, Second Department of Surgery
Zip code
Address
TEL
Homepage URL
unno@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Universtiy School of Medicine
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | 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
measurement of lymphatic pumping pressure.
Assessment with SF-36
Management information
Registered date
| 2010 | Year | 12 | Month | 30 | Day |
Last modified on
| 2010 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005725
