UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033425 |
|---|---|
| Receipt number | R000038113 |
| Scientific Title | The usefulness of a three-microneedle device for the indocyanine green fuluorescence lymphangiography |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2019/07/19 15:14:07 |
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Basic information
Public title
The usefulness of a three-microneedle device for the indocyanine green fuluorescence lymphangiography
Acronym
The usefulness of a three-microneedle device for the ICG lymphangiography
Scientific Title
The usefulness of a three-microneedle device for the indocyanine green fuluorescence lymphangiography
Scientific Title:Acronym
The usefulness of a three-microneedle device for the ICG lymphangiography
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ICG fluorescence lymphography is widespread for the diagnosis of lymphedema or observation of lymphatic vessels during surgery. However, the injection method has been unified and not been improved. Recently, the three-microneedle device (Paskin, Nanbu Plastics Co, Ltd, Japan) was developed and the usefulness in the local anethsesia had been reported. The objective of this study is to investigate the usefulness of the three-microneedle device (TMD) in the fluorescence lymphography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We studied the depth of injected intradermal area of ICG solution with the three-microneedle device
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have consented to use in this research by consent form
Key exclusion criteria
Patient who offered not to participate in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Inuzuka |
Organization
Hamamatsu University School of Medicne
Division name
Second Deparment of Surgery
Zip code
Address
1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL
053-435-2279
inu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Kayama |
Organization
Hamamatsu University School of Medicine
Division name
Second Deparment of Surgery
Zip code
Address
1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL
053-435-2279
Homepage URL
d16007@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
YES
Study ID_1
18-062
Org. issuing International ID_1
Hamamatsu University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Human lower limb after amputation for critical limb ischemia was harvested and used for this study. ICG solution (0.5%, 0.1ml) was injected intradermaly at each skin site immediately after lower limb amputation. A threemicro-needle device or a 27-G needle was used for the injection at each 10 skin site. The injected skin sites were excised with surrounding subcutaneous and adipose tissues. Skin tissues were fixed in 10% formalin at room temperature for 24 hours, and embedded in paraffin. To observe the depth of ICG injection, near infrared fluorescence microscopy was also performed.
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038113
| 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 |
