UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012769 |
|---|---|
| Receipt number | R000013530 |
| Scientific Title | Vomumetric measurements of patient with lymphedema in daily fluctuation using 3D volume instrument |
| Date of disclosure of the study information | 2014/01/10 |
| Last modified on | 2014/01/06 22:27:22 |
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Basic information
Public title
Vomumetric measurements of patient with lymphedema in daily fluctuation using 3D volume instrument
Acronym
Vomumetric measurements of patient with lymphedema in daily fluctuation
Scientific Title
Vomumetric measurements of patient with lymphedema in daily fluctuation using 3D volume instrument
Scientific Title:Acronym
Vomumetric measurements of patient with lymphedema in daily fluctuation
Region
| Japan |
Condition
Condition
patient with lymphedema recieved LVA and normal subject
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Judge the 3D volumetric instrument can assesse the treatment efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
On the preoperative day and post operative day 3 ,4 and 5, extremities volume is measured on the each morning and evening in patient with lymphedema.
Key secondary outcomes
On the random 3 days, extremities volume is measured on the each morning and evening in normal subject.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
40 patients which admitted to a hospital to recieve the LVA
10 healthy subjects
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
A patient with in treatment at Okayama university.A patient is admitted to a hospital. A patient is recieved sufficient explanation and has a fair understanding of the examination.
A patient is adult.
A patient is managed conservatively.
Key exclusion criteria
Doctor is decided on inappropriate patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Yamada |
Organization
Okayama University Hospital
Division name
plastic surgery
Zip code
Address
2-5-1 Shikata-tyo Okayama-shi Kita-ku Okayama-Pref
TEL
086-235-7214
yam_kiy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Katayama |
Organization
Okayama Unversity Hospital
Division name
plastic surgery
Zip code
Address
2-5-1 Shikata-tyo Okayama-shi Kita-ku
TEL
086-235-7214
Homepage URL
u_chopping@yahoo.co.jp
Sponsor or person
Institute
Okayama University Plastic Surgery
Institute
Department
Personal name
Funding Source
Organization
Okayama University Plastic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
岡山大学病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 10 | 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
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013530
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
