UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018719 |
|---|---|
| Receipt number | R000021588 |
| Scientific Title | A study to establish the standard procedure using ICG lymphography for lymphedema. |
| Date of disclosure of the study information | 2015/08/19 |
| Last modified on | 2015/08/19 14:38:46 |
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Basic information
Public title
A study to establish the standard procedure using ICG lymphography for lymphedema.
Acronym
A study to establish the standard procedure using ICG lymphography for lymphedema.
Scientific Title
A study to establish the standard procedure using ICG lymphography for lymphedema.
Scientific Title:Acronym
A study to establish the standard procedure using ICG lymphography for lymphedema.
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to establish the standard procedure using ICG lymphography for lymphedema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ascention point in every 5 minutes after ICG injection
Key secondary outcomes
existence or non-existence of dermal backflow in every 5 minutes after ICG injection
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
| Other |
Interventions/Control_1
exercise in ICG lymphography
6 sets of
walking on treadmill for 5 minutes (lower limb)
exercise of upper limb with a 500g wight for 5 minutes (upper limb)
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
1. Patients with edema of extremity .
2. over 20 years old
3. Patients with written consent
Key exclusion criteria
1. Patients who cannot exercise
2. Patients considered inappropriate by the study investigator
Target sample size
100
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-cho Okayama-shi Kita-ku Okayama-Pre
TEL
086-235-7214
yam_kiy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsumoto kumiko |
Organization
Okayama Univercity Hospital
Division name
plastic surgery
Zip code
Address
2-5-1 Shikata-cho Okayama-shi Kita-ku Okayama-Pref
TEL
086-235-7214
Homepage URL
gmd421061@s.okayama-u.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Okayama University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 08 | Month | 19 | 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
| 2014 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 28 | 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
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021588
