UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012769
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email u_chopping@yahoo.co.jp

Sponsor
Institute Okayama University Plastic Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.