UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024677 |
|---|---|
| Receipt number | R000028391 |
| Scientific Title | Safety of indocyanine green lymphography for evaluation of lymphedema |
| Date of disclosure of the study information | 2016/11/02 |
| Last modified on | 2018/06/30 08:58:43 |
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Basic information
Public title
Safety of indocyanine green lymphography for evaluation of lymphedema
Acronym
Indocyanine green lymphography for lymphedema
Scientific Title
Safety of indocyanine green lymphography for evaluation of lymphedema
Scientific Title:Acronym
Indocyanine green lymphography for lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Indocyanine green lymphography (ICG)is applied to clinical widely as a liver function test.These days, ICG is performed for evaluation of lymphedema as a preoperative examination.However, the side effects of ICG are not examined. Then, we perform ICG for lyphedema under medical treatment insurance adaptation outside (patient own expense) and evaluated the safety. Specifically, we carry out observation of whethe the general side effects (shock, nausea, blood vessel pain, fever)of ICG occur.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Check whether there are side effects (shock, nausea, blood vessel pain, fever)
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
We carry out local injection of ICG at dorsum of foot and the inside of foot joint intra- or subcutaneously. We trace the flow of ICG with an infrared observation camera. We carry out observation of whether side effects (shock, nausea, blood vessel pain, fever)happen.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person by whom lymphedema continued three months or more and written consent was got.
Key exclusion criteria
Those who have the past of hypersensitivity to iodine. Those who are judged that experimental participation is difficul by moral condition. A pregnant woman, a nursing mother. Moreover, those possible of pregnancy. The person to whom the doctor judged participation of the final examination to be unsuitable.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Toriyama |
Organization
Nagoya City University Hospital
Division name
Plastic and reconstructive surgery
Zip code
Address
1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-858-7514
toriyama@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahumi Uchibori |
Organization
Nagoya City University Hospital
Division name
Plastic and reconstructive surgery
Zip code
Address
1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-858-7514
Homepage URL
uchibori83@gmail.com
Sponsor or person
Institute
Nagoya city university hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 11 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 11 | 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
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028391
