UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033425
Receipt No. 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

* 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 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
Email 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
Email d16007@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.