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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002284
Receipt No. R000002781
Scientific Title The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion.
Date of disclosure of the study information 2009/08/03
Last modified on 2015/08/03

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Basic information
Public title The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion.
Acronym Indocyanine Green fluorescence navigation surgery for vascular or lymphatic perfusion.
Scientific Title The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion.
Scientific Title:Acronym Indocyanine Green fluorescence navigation surgery for vascular or lymphatic perfusion.
Region
Japan

Condition
Condition peripheral vascular disease
peripheral lymphatic disease
flap surgery
vasulular insufficiency
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the operation of plastic surgery, evaluation of vascular or lymphatic perfusion is mandatory. To evaluate these status, ultrasound sonography(US), computed tomography(CT), magnetic resonance imaging(MRI), angiography(AG) are utilized. The US have an advantage with respect to evaluate dynamic perfusion of vessels and lymph channels. However, it is inadequate to estimate whole imaging of the lesion.The CT and MRI are used validly to estimate whole imaging of the lesion, however the dynamic perfusion of vessels and lymph channels are not evaluated easily with CT or MRI. The dynamic perfusion can be evaluated with AG. Performing AG is time-comsuming. CT and AG have another difficulty of the radioactive exposure.
Indocyanine Green (ICG) expresses fluorescent character when ICG is injected to biological body. This fluorescent character can be examined with near infrared camera (Photodynamic Eye, PDE, ). To use ICG and PDE, the status of vessels and lymph channels can be easily evaluated as follows; dynamic perfusion, whole imaging. This technique is less-invasive, not time-comsuming,have few complications, and require no radioactive exposure.The intraoperative imaging of lesion can be possible.
In this study, The efficacy of ICG fluorescent imaging is analyzed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ability to evaluate whole imaging and dynamic status of vessels and lymph channels.
The ability to evaluate intraoperative and postoperative vascular channels of flaps.
The abilty to evaluate vascular insufficiency.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Indocyanine Green
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
0 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The patient with peripheral vascular disease or peripheral lymphatic disease
The patient who is undertaken flap surgery
The patient with vascular insufficiency
Key exclusion criteria The patient with previous illness of ICG anaphylaxis.
The patient with previous illness of iodine anaphylaxis.
The pregnant female.
The nursing female.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunobu Hashikawa
Organization Kobe University Hospital
Division name Plastic Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5111
Email kazunobu@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruo Ogawa
Organization Kobe University Hospital
Division name Plastic Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5111
Homepage URL
Email yeraishan@yahoo.co.jp

Sponsor
Institute Department of Plastic Surgery, Kobe University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 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
2009 Year 08 Month 03 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 Completed
Date of protocol fixation
2009 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 03 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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