UMIN-CTR Clinical Trial

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 Toshifumi Middle name Last name Kudo
Organization	Tokyo Medical and Dental University
Division name	Vascular Surgery
Zip code	113-8519
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 Tsuyoshi Middle name Last name Ichinose
Organization	Tokyo Medical and Dental University
Division name	Vascular Surgery
Zip code	113-8519
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	Vascular Surgery, Tokyo Medical and Dental University
Address	Yushima 1-5-45, Bunkyouku, Tokyo
Tel	03-3813-6111
Email	ichisurg2@tmd.ac.jp

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	東京医科歯科大学病院（東京都）

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	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 28 Day
Date of IRB	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
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	2021 Year 06 Month 13 Day

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