UMIN-CTR Clinical Trial

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