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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025202
Receipt No. R000028990
Scientific Title The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM.
Date of disclosure of the study information 2016/12/09
Last modified on 2016/12/09

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Basic information
Public title The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM.
Acronym A-V shunt limb blood flow evaluation using OX Imager CS TM.
Scientific Title The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM.
Scientific Title:Acronym A-V shunt limb blood flow evaluation using OX Imager CS TM.
Region
Japan

Condition
Condition Hemodialysis access induced distal ischemia
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the prompt and non-invasive method for the evaluation of the hemdialysis access induced distal ischemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Wether it is possible to make diagnosis of ischemia by using OX Imager CS TM
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Record images using OX Imager CS TM and evaluate the blood flow and analyse the results.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients of hemodialysis induced distal ischemia under care of our division or The patients of hemodialysis induced distal ischemia who will be taken care in future(male and female).
2. The patient who has arteriovenous fistula as a vascular access without access induced distal ischemia.
3. The patients who agreed to participate this study with written informed consent.
Key exclusion criteria 1. The patients determined by the investigator to be unstable as a subject in this study.
2. The patients without written informed consent.
3. The patients less than 20 years old.
4. The patients with dementia.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Inoue
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
Address Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL 03-3813-5255
Email yoshi.inoue.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Ichinose
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
Address Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL 03-5803-5255
Homepage URL
Email ichinose.srg2@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
2016 Year 12 Month 09 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 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 12 Month 09 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028990

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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